FDA Adverse Event
Malfunction
Summary report: N
J-VAC RESERVOIR
MDR report key: 1242996
·
Received November 20, 2008
Report
- Report Number
- 2210968-2008-01155
- Event Type
- Malfunction
- Date Received
- November 20, 2008
- Date of Event
- October 16, 2008
- Report Date
- October 22, 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: 11/20/2008. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
INTERNATIONAL CUSTOMER REPORTED THAT THE DEVICE WAS FILLED WITH AIR PRIOR TO THE FIRST ACTIVATION CYCLE. THIS EVENT WAS OBSERVED DURING THE PROCESS OF ACTIVATING THE DEVICE. NO ADVERSE PT 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 | 730654 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | DRAIN - SURGICAL - NO SPECIFIED. |