FDA Adverse Event
Injury
Summary report: N
WALLSTENT ENTERAL PROSTHESIS
MDR report key: 234549
·
Received August 3, 1999
Report
- Report Number
- 6000102-1999-00003
- Event Type
- Injury
- Date Received
- August 3, 1999
- Date of Event
- June 28, 1999
- Report Date
- July 7, 1999
- Manufacturer
- PLYMOUTH TECHNOLOGY CENTER
- Product Code
- MQR
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING EMERGENT COLONIC STENT PROCEDURES PERFORMED 06/24/1999 AND 06/25/1999, THE PATIENT WAS DIAGNOSED AS HAVING A PERFORATED COLON. THE PATIENT WAS SENT TO SURGERY AND THE STATUS IS UNK AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WALLSTENT ENTERAL PROSTHESIS Implant | ENTERAL STENT | MQR | PLYMOUTH TECHNOLOGY CENTER | BARE 22X90 10FR ENTERAL 255CM | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |