FDA Adverse Event Injury Summary report: N

WALKING CHAIR EVA STANDARD WITH ACCESSORIES

MDR report key: 7278 · Received December 13, 1993

Report

Report Number
7278
Event Type
Injury
Date Received
December 13, 1993
Date of Event
December 12, 1993
Report Date
December 13, 1993
Manufacturer
LIC REHAB CARE
Product Code
ITJ
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

AT 0645 HRS, OUTSIDE BATHROOM DOORWAY ON 3RD FLOOR. RESIDENT AMBULATED SELF WITH WHEEL WALKER AND FELL ONTO THE FLOOR LANDING ON HER RIGHT HAND. NOTICED BLOOD AND BLEEDING FROM THE RING FINGER ON RIGHT HAND NEAR FINGERNAIL. DIAGNOSIS: OPEN FRACTURE OF DISTAL PHALANX RIGHT RING FINGER WITH SOFT TISSUE AVULSION. PROCEDURE: AMPUTATION OF DISTAL IP JOINT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 WALKING CHAIR EVA STANDARD WITH ACCESSORIES ITJ LIC REHAB CARE 710853.4

Patients

Seq Age Sex Outcome Treatment
1 * Required Intervention