SILASTIC (R) CARPAL LUNATE IMPLANT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-05-20 for SILASTIC (R) CARPAL LUNATE IMPLANT UNK manufactured by Dow Corning Corp..

Event Text Entries

[58935] Attorney alleges plaintiff suffers the following symptoms: deterioration of the wrist, hand and arm; severe pain, discoloration, swelling, distortion; reduced wrist, hand and arm mobility; chronic and continous pain throughout the area causing chronic fatigue and depression; unnecessary exposure to autoimmune diseases and additional corrective surgery and treatment. Attorney also alleges plaintiff suffers from emotional nervous upset occasioned by his injuries and disabilities.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1816403-1997-00532
• MDR Report Key: 92480
• Report Source: 00
• Date Received: 1997-05-20
• Date of Report: 1997-04-23
• Date Mfgr Received: 1997-04-23
• Date Added to Maude: 1997-05-23
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: ATTORNEY
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SILASTIC (R) CARPAL LUNATE IMPLANT
• Generic Name: CARPAL LUNATE IMPLANT
• Product Code: KWN
• Date Received: 1997-05-20
• Model Number: NA
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: NA
• Operator: OTHER
• Device Availability: N
• Device Age: *
• Device Eval'ed by Mfgr: N
• Implant Flag: Y
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 91339
• Manufacturer: DOW CORNING CORP.
• Manufacturer Address: 2200 WEST SALZBURG RD AUBURN MI 48611 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-05-20