FDA Adverse Event
Injury
Summary report: N
J & J ETHICON
MDR report key: 395947
·
Received May 23, 2002
Report
- Report Number
- 395947
- Event Type
- Injury
- Date Received
- May 23, 2002
- Date of Event
- March 22, 2002
- Report Date
- April 4, 2002
- Manufacturer
- ETHICON, INC., QA
- Product Code
- GCY
- Report Source
- User Facility report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A PT WITH SEVERE END-STAGE COPD AND UTERINE CARCINOMA THAT HAD ERODED INTO THE SMALL BOWEL UNDERWENT SURGERY FOR THE OVARIAN MASS RESECTION AND PARTIAL COLECTOMY. THE PT REQUIRED A REPEAT EXPLORATION TO REMOVE A PORTION OF A SURGICAL DRAIN WHICH WAS RETAINED DURING AN ATTEMPT TO REMOVE IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | J & J ETHICON | 19 FR. BLAKE DRAIN | GCY | ETHICON, INC., QA | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |