FDA Adverse Event Injury Summary report: N

VHA + PLUS LAPAROTOMY SPONGES

MDR report key: 7500 · Received January 9, 1994

Report

Report Number: 7500
Event Type: Injury
Date Received: January 9, 1994
Date of Event: September 8, 1993
Report Date: September 21, 1993
Manufacturer: MEDICAL ACTION
Product Code: FGS
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

RECEIVED NOTIDICATION VIA VHA URGENT RECALL NOTICE DATED 9/8/93 ON 9/14/93 REGARDING RECALL OF LAPAROTOMY SPONGES LOT #'S 100 - 1434. PRODUCTS PULLED ON 9/14/94. 9/17/93 NOTIFIED MFG. REPRESENTATIVE THAT STERILE PRODUCTS UNAVAILABLE. PLAN ESTABLISHED TO MAINTAIN SERVICE. ORDERED STERILE STOCK FROM OTHER COMPANIES. USED PRE-PACKAGED STERILE SUPPLIES. REPORT TO SURGERY CHIEF AND INFECTION CONTROL FUNCTION. SOURCE OF PROBLEM: STERILIZATION OF PRODUCT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VHA + PLUS LAPAROTOMY SPONGES	LAPAROTOMY SPONGES	FGS	MEDICAL ACTION	N/A	100 - 1434

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other