PlainHospital

PLEXUS MANUFACTURING SDN. BHD

Manufacturer adverse-event records for PLEXUS MANUFACTURING SDN. BHD come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2011–2021 · thin-book · typical Death-code · injury-light

Volume signature

PLEXUS MANUFACTURING SDN. BHD is a thinner MAUDE footprint

PLEXUS MANUFACTURING SDN. BHD accounts for 5,574 FDA MAUDE reports (#342 of 443, thin-book tercile). Death-coded event_type share is 0.14% (typical); Injury share 6.7% (injury-light).

What the volume reading shows for PLEXUS MANUFACTURING SDN. BHD

The standout signal for PLEXUS MANUFACTURING SDN. BHD is filing volume: 5,574 adverse-event reports in FDA MAUDE (#342 of 443, thin-book). Death-coded event_type share sits at 0.14% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 14 device types, led in this extract by Malfunction at 5,192 (93.1% of event_type total). Peak single-year volume reaches 1,349 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,574
Total Reports
8
Event-type Death
374
Injury Reports
14
Device Types

Event Types

Malfunction 5,192 (93.1%)
Injury 374 (6.7%)
Death 8 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

5,132 (90.5%)
Required Intervention 231 (4.1%)
Other 88 (1.6%)
R 87 (1.5%)
Life Threatening 82 (1.4%)
Hospitalization 33 (0.6%)
Death 8 (0.1%)
L 5 (0.1%)
O 4 (0.1%)

Devices (14)

Device Reports
Pulse-Generator, Pacemaker, External 3,966
Pulse Generator, Permanent, Implantable 558
Programmer, Pacemaker 523
Analyzer, Pacemaker Generator Function 238
Stimulator, Electrical, Implantable, For Incontinence 167
Pacemaker/Icd/Crt Non-Implanted Components 48
Implantable Pulse Generator, Pacemaker (Non-Crt) 31
Detector And Alarm, Arrhythmia 23
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief 10
Cardiac Ablation Percutaneous Catheter 5
Oximeter 2
Cable, Transducer And Electrode, Patient, (Including Connector) 1
Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence 1
System, Thermal Regulating 1

Yearly Trend

11
2011: 27
12
2012: 25
13
2013: 13
14
2014: 76
15
2015: 433
16
2016: 572
17
2017: 818
18
2018: 1,195
19
2019: 1,349
20
2020: 1,061
21
2021: 5

Read our methodology - how this data is sourced, computed, and verified.