FDA Adverse Event
Injury
Summary report: N
SILASTIC (R) CARPAL LUNATE IMPLANT
MDR report key: 92480
·
Received May 20, 1997
Report
- Report Number
- 1816403-1997-00532
- Event Type
- Injury
- Date Received
- May 20, 1997
- Report Date
- April 23, 1997
- Manufacturer
- DOW CORNING CORP.
- Product Code
- KWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILASTIC (R) CARPAL LUNATE IMPLANT Implant | CARPAL LUNATE IMPLANT | KWN | DOW CORNING CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |