FDA Adverse Event
Malfunction
Summary report: N
TRUFIT CB PLUG KITS
MDR report key: 1890340
·
Received November 3, 2010
Report
- Report Number
- 1219602-2010-00271
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Report Date
- November 2, 2010
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
- Product Code
- MQV
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED FOR EVALUATION. (B)(4)
Description of Event or Problem · 1
PATIENT EXPERIENCED POST-OP CONDITION WITH SEVERE PAIN 10 MONTHS AFTER THE DEVICE IMPLANTATION. IT SHOWS EFFUSION , SOFT AND CREAMED TISSUE INTO DEFECT. DR. FILLED WITH OTHER COMPETITOR'S PLUG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFIT CB PLUG KITS | UNKNOWN TRUFIT DEVICE | MQV | SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |