UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-10 for UNK manufactured by Unk.

Event Text Entries

[364235] Pt admitted to hospital for removal of retained silastic prosthesis of left wrist secondary to left wrist swelling, pain, numbness, tingling, and burning in both arms. During surgery it was noted that pt had extensive synovitis, diffuse carpal, radial, and ulnar erosion due to synovitis. Surgeon performed excision of fragmented implant, interpostional arthroplasty distal radial ulnar joint, wrist arthrodesis proximal row carpectomy, and extensive excision of intercarpal and inter radial synovitic erosion. The original implant was placed 17 years ago.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 529119
• MDR Report Key: 529119
• Date Received: 2004-06-10
• Date of Report: 2004-05-28
• Date of Event: 2004-03-01
• Date Facility Aware: 2004-05-20
• Report Date: 2004-05-28
• Date Added to Maude: 2004-06-11
• 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: 3
• Reporter Occupation: RISK MANAGER
• 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: UNK
• Generic Name: SILASTIC WRIST PROSTHESIS
• Product Code: KWM
• Date Received: 2004-06-10
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 17 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 518330
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-06-10