MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for J-VAC SUCTION RESERVIOR 2161 manufactured by Johnson And Johnson.
[6454]
J-vac was removed from patient with no resistance. Part of j-vac drain was retained and patient had retained portion surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17537 |
| MDR Report Key | 17537 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-03-29 |
| Date of Event | 1994-03-27 |
| Date Facility Aware | 1994-03-28 |
| Report Date | 1994-03-29 |
| Date Reported to Mfgr | 1994-03-30 |
| Date Added to Maude | 1994-11-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J-VAC SUCTION RESERVIOR |
| Generic Name | CLOSED WOUND DRAINAGE KIT |
| Product Code | EYZ |
| Date Received | 1994-07-29 |
| Model Number | 2161 |
| Catalog Number | 2161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 17458 |
| Manufacturer | JOHNSON AND JOHNSON |
| Manufacturer Address | P.O. BOX 4000 NEW BRUNSWICK NJ 08903 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-29 |