FDA Adverse Event Injury Summary report: N

STIEGMANN-GOFF LIGATOR KIT

MDR report key: 1524 · Received September 28, 1992

Report

Report Number: 1221332-1992-00028
Event Type: Injury
Date Received: September 28, 1992
Date of Event: August 20, 1992
Report Date: September 10, 1992
Manufacturer: SUPERIOR HEALTH CARE GROUP, INC.
Product Code: FHN
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: FL, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

THE PHYSICIAN STATES THAT A 51 YEAR OLD MALE PRESENTED FOR AN UNEVENTFUL BANDING OF THREE VARICES ON 8/10/92. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE WITHOUT COMPLICATION. ON 8/20/92, THE PATIENT RETURNED WITH ACTIVE BLEEDING FROM TWO ULCERS JUST UNDER THE RESPECTIVE BANDED VARIX. HIGH DOSE SCLEROSING WAS PERFORMED WITHOUT SUCCESS. THE SAME DAY THE DECISION WAS MADE TO DO A TRANSJUGULAR INTERHEPATIC PORTOSYSTEMIC SHUNT. THE PATIENT REMAINS IN STABLE CONDITION IN THE INTENSIVE CARE UNITDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STIEGMANN-GOFF LIGATOR KIT Implant	N/A	FHN	SUPERIOR HEALTH CARE GROUP, INC.	UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Required Intervention