CODMAN & SHURTLEFF, INC.

FDA MAUDE device safety record · 1992–2022

What the Data Shows About CODMAN & SHURTLEFF, INC.

CODMAN & SHURTLEFF, INC. is associated with 3,668 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1992 through 2022. Of the total, 27 are coded as death reports and 2,354 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 CODMAN & SHURTLEFF, 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 2,354 reports (64.2% of total). Patient-outcome categorizations are reported across 10 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 28 years of MAUDE data, with the peak single-year volume reaching 487 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.

3,668
Total Reports
27
Death Reports
2,354
Injury Reports
20
Device Types

Event Types

Injury 2,354 (64.2%)
Malfunction 1,269 (34.6%)
Death 27 (0.7%)
10 (0.3%)
Other 8 (0.2%)

Patient Outcomes

Required Intervention 2,088 (56.3%)
1,140 (30.8%)
Other 392 (10.6%)
R 30 (0.8%)
Death 27 (0.7%)
Hospitalization 20 (0.5%)
L 3 (0.1%)
Life Threatening 3 (0.1%)
O 2 (0.1%)
S 2 (0.1%)

Yearly Trend

92
1992: 2
93
1993: 3
94
1994: 4
95
1995: 2
96
1996: 3
00
2000: 78
01
2001: 97
02
2002: 128
03
2003: 126
04
2004: 141
05
2005: 115
06
2006: 61
07
2007: 67
08
2008: 79
09
2009: 86
10
2010: 187
11
2011: 79
12
2012: 11
13
2013: 487
14
2014: 443
15
2015: 271
16
2016: 210
17
2017: 313
18
2018: 486
19
2019: 165
20
2020: 15
21
2021: 8
22
2022: 1

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.