DAVOL INC., SUB. C.R. BARD, INC.

FDA MAUDE device safety record · 2004–2025

What the Data Shows About DAVOL INC., SUB. C.R. BARD, INC.

DAVOL INC., SUB. C.R. BARD, INC. is associated with 57,503 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2004 through 2025. Of the total, 373 are coded as death reports and 55,675 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for DAVOL INC., SUB. C.R. BARD, INC. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Injury at 55,675 reports (96.8% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 22 years of MAUDE data, with the peak single-year volume reaching 10,170 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

57,503
Total Reports
373
Death Reports
55,675
Injury Reports
20
Device Types

Event Types

Injury 55,675 (96.8%)
Malfunction 1,247 (2.2%)
Death 373 (0.6%)
Other 183 (0.3%)
25 (0.0%)

Patient Outcomes

Required Intervention 32,978 (50.2%)
Disability 19,538 (29.8%)
S 4,052 (6.2%)
R 3,705 (5.6%)
Other 2,127 (3.2%)
1,304 (2.0%)
Hospitalization 859 (1.3%)
Life Threatening 332 (0.5%)
Death 309 (0.5%)
L 259 (0.4%)
H 75 (0.1%)
D 67 (0.1%)
O 45 (0.1%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

04
2004: 88
05
2005: 168
06
2006: 336
07
2007: 873
08
2008: 570
09
2009: 523
10
2010: 574
11
2011: 305
12
2012: 557
13
2013: 633
14
2014: 439
15
2015: 427
16
2016: 586
17
2017: 1,132
18
2018: 4,355
19
2019: 10,170
20
2020: 9,392
21
2021: 8,736
22
2022: 7,338
23
2023: 5,229
24
2024: 4,906
25
2025: 166

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.