FDA Adverse Event Injury Summary report: N

STOP LEAK GEL CUSHION

MDR report key: 7266 · Received December 27, 1993

Report

Report Number: 7266
Event Type: Injury
Date Received: December 27, 1993
Date of Event: November 30, 1993
Report Date: December 1, 1993
Manufacturer: JEFFERSON GEL CO.
Product Code: KNN
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

RESIDENT AMBULATING IN LOUNGE AND SLIPPED ON GEL THAT HAD LEAKED OUT OF BROKEN GEL PAD. RESIDENT HIT RIGHT FOREHEAD, HEMATOMA RESULTED. COMPLAINED OF RIGHT WRIST HURTING AFTER 1 MIN OF UNRESPONSIVENESS. X-RAY TAKEN; RIGHT WRIST FRACTURED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: ENVIRONMENTAL FACTORS. CONCLUSION: DEVICE FAILURE INDIRECTLY CONTRIBUTED TO EVENT. 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	STOP LEAK GEL CUSHION	NA	KNN	JEFFERSON GEL CO.	1277	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR		Required Intervention