FDA Adverse Event Injury Summary report: N

GASTRANIMALS

MDR report key: 3488 · Received July 29, 1992

Report

Report Number: 3488
Event Type: Injury
Date Received: July 29, 1992
Date of Event: December 31, 1991
Report Date: January 9, 1992
Manufacturer: APPLIED MEDICAL TECHNOLOGY, INC.
Product Code: EYN
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

12/31/91 PATIENT HAD PIG INSERTION. RETURNED TO SURGERY ON 12/18/91. PATIENT RETURNED TO SURGERY FOR GASTRORRHAPY AND A LAPAROTOMY AND REPLACEMENT OF PIG WAS PERFORMED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GASTRANIMALS Implant	P.I.G. SILICONE INITIAL PLACEMENT GASTROSTOMY TRAY 15FR	EYN	APPLIED MEDICAL TECHNOLOGY, INC.	15FR	071891

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR		Other