FDA Adverse Event
Malfunction
Summary report: N
J-VAC RESERVOIR
MDR report key: 1191111
·
Received September 26, 2008
Report
- Report Number
- 2210968-2008-00913
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 29, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- GCY
- PMA / PMN Number
- K953655
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 09/26/2008. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
INTERNATIONAL CUSTOMER REPORTS THAT A TEAR WAS OBSERVED AROUND THE UPPER LEFT HEAT SEAL OF THE RESERVOIR SIX DAYS AFTER PLACING THE DEVICE IN SERVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J-VAC RESERVOIR | WOUND DRAINAGE SYSTEM | GCY | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | DRAIN - SURGICAL - NOT SPECIFIED |