NORPLANT SYSTEM

Report

Report Number: 3157
Date Received: January 22, 1993
Date of Event: July 26, 1992
Report Date: August 6, 1992
Manufacturer: WYETH - AYERST LABORATORIES
Product Code: MFH
Adverse Event: Yes
Report Source: User Facility report
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

PATIENT PRESENTED TO EMERGENCY ROOM ON 7/24/92 WITH EDEMA AND ERYTHEMA ON LEFT ARM, AT SITE OF IMPLANT. GIVEN ANTIBIOTIC AND ADVISED TO RETURN IF CONDITION WORSENED. RETURNED TO EMERGENCY ROOM ON 7/26/92 WITH APPARENT CELLUTITIS OF LEFT UPPER ARM. NORPLANT REMOVED ON 7/27/92. PATIENT WAS DISCHARGED ON 7/29/92 MUCH IMPROVED. BAYSTATE MEDICAL CENTER SUBMITS THIS REPORT PURSUANT TO PROVISIONS OF 21 CFR PART 803. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY BAYSTATE MEDICAL CENTER THAT IT OR ANY OF ITS EMPLOYEES OR AFFILIATES CAUSED OR CONTRIBUTED TO THE INCIDENT DESCRIBED HEREIN.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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NORPLANT SYSTEM Implant	LEVONORGESTREL IMPLANTS	MFH	WYETH - AYERST LABORATORIES	N/A	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	22 YR		Required Intervention