BREAST PROSTHESIS NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-27 for BREAST PROSTHESIS NI manufactured by Dow Corning.

Event Text Entries

[19551575] Painful breastinvalid data - regarding single use labeling of device. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4761
• MDR Report Key: 4761
• Date Received: 1993-04-27
• Date of Report: 1993-04-21
• Report Date: 1993-04-21
• Date Reported to Mfgr: 1992-04-08
• Date Added to Maude: 1993-06-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BREAST PROSTHESIS
• Generic Name: N/A
• Product Code: KCZ
• Date Received: 1993-04-27
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: SIZE 200 LP
• Operator: OTHER
• Device Availability: N
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4477
• Manufacturer: DOW CORNING

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-04-27