FDA Adverse Event Injury Summary report: N

BREAST IMPLANTS

MDR report key: 3248 · Received January 26, 1993

Report

Report Number: 3248
Event Type: Injury
Date Received: January 26, 1993
Date of Event: November 25, 1992
Report Date: December 3, 1992
Manufacturer: DOW CORNING MAMMARY IMPLANTS
Product Code: KCZ
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

PATIENT WITH DIAGNOSIS OF BILATERAL BREAST CAPSULES. ON 11/25/92 HAD REMOVAL OF BILATERAL BREAST IMPLANTS, BILATERAL CAPSULECTOMY. IMPLANTS WERE INTACT UPON REMOVAL.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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	Implant	BREAST IMPLANTS	KCZ	DOW CORNING MAMMARY IMPLANTS

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR		Required Intervention