FDA Adverse Event
Injury
Summary report: N
CODMAN/J & J
MDR report key: 304243
·
Received November 2, 2000
Report
- Report Number
- MW1020371
- Event Type
- Injury
- Date Received
- November 2, 2000
- Date of Event
- June 8, 2000
- Report Date
- October 30, 2000
- Manufacturer
- CODMAN HEALTH CARE
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT IN OR FOR REPAIR OF LEFT INGUINAL HERNIA, WHICH WAS COMPRISED OF SOME COLON. PROCEDURE WAS COMPLICATED BECAUSE OF SCARRING. MULTIPLE ATTEMPTS AT DISSECTING COLON FREE. PORTIONS OF COLONIC LOOP BEGAN TO DEVASCULARIZE PROBABLY FROM TRACTION ON MESENTERIC VESSELS. PT REQUIRED RESECTION OF COLON TO PERFORM PRIMARY ANASTOMOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN/J & J | WEITLANDER SHARP 7.5 RETRACTOR | GAD | CODMAN HEALTH CARE | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |