FDA Adverse Event Malfunction Summary report: N

UNKNOWN

MDR report key: 7748 · Received February 4, 1994

Report

Report Number: 7748
Event Type: Malfunction
Date Received: February 4, 1994
Date of Event: July 20, 1993
Report Date: July 22, 1993
Manufacturer: N/A
Product Code: FTR
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

41 YEAR OLD FEMALE WITH BILATERAL SILICONE BREAST IMPLANTS PERFORMED APPROXIMATELY 13 YEARS AGO. LEFT BREAST IMPLANT LEAKED AND BECAME INFECTED AND WAS REMOVED ON 6/24/93. ADMITED TO THE HOSPITAL ON 7/8/93 FOR AGGRESSIVE TREATMENT OF INFECTION, WITH GOOD RESULTS. DISCHARGED 7/19/93. ON 7/20/93 NOTIFIED THE PHYSICIAN THAT THE RIGHT BREAST WAS TENDER AND CHANGING IN SIZE. TAKEN TO THE OPERATING ROOM ON 7/20/93 AND RIGHT BREAST IMPLANT REMOVED.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNKNOWN Implant	SILICONE BREAST IMPLANT	FTR	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR		Other