FDA Adverse Event
Malfunction
Summary report: N
3/32" END PERF SILICONE DRAIN WITH TROCAR
MDR report key: 1243085
·
Received November 21, 2008
Report
- Report Number
- 1526350-2008-00041
- Event Type
- Malfunction
- Date Received
- November 21, 2008
- Date of Event
- July 17, 2008
- Report Date
- October 23, 2008
- Manufacturer
- ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
- Product Code
- GCY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVACUATOR, CONNECTOR, AND DRAIN WERE RETURNED FOR EVALUATION. EVACUATOR CONTAINED A "DEVOL" LABEL. THE OPERATOR REPORT STATED THE DRAIN WAS A 00-2540-021-10, WHICH IS A ZIMMER CATALOG NUMBER. DRAIN WAS EVALUATED AND FOUND TO MEET SPECIFICATIONS. UNABLE TO DETERMINE CAUSE OF BREAK. SUTURE WAS WRAPPED AROUND DRAIN WHEN RECEIVED TO ZIMMER OSP.
Description of Event or Problem · 1
TUBE BROKE WHEN REMOVING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3/32" END PERF SILICONE DRAIN WITH TROCAR | SILICONE DRAIN WITH TROCAR | GCY | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |