* UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-17 for * UNK manufactured by Unk.

Event Text Entries

[20438825] Pt had pain and deformity of left wrist. Surgery done to replace silastic wrist implant. Implant found to be fractured completely at distal extension.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 129328
• MDR Report Key: 129328
• Date Received: 1997-10-17
• Date of Report: 1997-10-15
• Date of Event: 1997-10-07
• Date Facility Aware: 1997-10-07
• Report Date: 1997-10-15
• Date Reported to FDA: 1997-10-15
• Date Added to Maude: 1997-11-04
• 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: 3
• Initial Report to FDA: 3
• 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: *
• Generic Name: SILASTIC WRIST IMPLANT
• Product Code: KIG
• Date Received: 1997-10-17
• Model Number: UNK
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 126504
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	1997-10-17