FDA Adverse Event
Other
Summary report: N
J-VAC
MDR report key: 13744
·
Received June 3, 1994
Report
- Report Number
- MW1002350
- Event Type
- Other
- Date Received
- June 3, 1994
- Date of Event
- April 28, 1994
- Report Date
- May 17, 1994
- Manufacturer
- JOHNSON & JOHNSON PRODUCTS, INC.
- Product Code
- GCY
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PRODUCT WAS INSERTED DURING SURGICAL PROCEDURE. PT RETURNED TO SURGERY DUE TO PERSISTENT DRAINAGE, AND APPROXIMATELY 6 INCHES OF DRAIN WAS REMOVED. THE NURSES STATED THE PT HAD ROLLED OVER IN BED SEVERAL DAYS BEFORE RETURNING TO SURGERY, AND NURSE HAD FOUND A DRAIN IN THE PT'S BED. THE DRAIN THAT THE NURSE FOUND WAS THOUGHT TO BE THE ENTIRE DRAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J-VAC | CLOSED DRAIN | GCY | JOHNSON & JOHNSON PRODUCTS, INC. | 17769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |