FDA Adverse Event
Injury
Summary report: N
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SYSTEM
MDR report key: 217755
·
Received April 7, 1999
Report
- Report Number
- 1037905-1999-00010
- Event Type
- Injury
- Date Received
- April 7, 1999
- Date of Event
- March 5, 1999
- Report Date
- March 26, 1999
- Manufacturer
- WILSON-COOK MEDICAL, INC.
- Product Code
- KNT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE PHYSICIAN SUCCESSFULLY PLACED A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE IN A FEMALE PATIENT WITH MEDICAL CONDITIONS UNKNOWN ON 1/15/99. IT WAS NOTED THAT THE INTERNAL BOLSTER MIGRATED INTO THE ABDOMINAL WALL CAUSING AN ABSCESS. ANTIBIOTICS WERE GIVEN TO THE PATIENT TO TREAT THE ABSCESS AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE TUBE WAS REMOVED AND REPLACED ON 3/5/99. NO FURTHER INFORMATION WAS AVAILABLE. THE INSTRUCTIONS FOR USE CAUTION "ALWAYS NOTE THE CENTIMETER MARKING CLOSEST TO THE TOP OF THE EXTERNAL BOLSTER BEFORE FEEDING TO CONFIRM THE TUBE IS IN THE PROPER POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SYSTEM Implant | FEEDING TUBE | KNT | WILSON-COOK MEDICAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |