FDA Adverse Event Injury Summary report: N

HBR HEALTHCARE CO

MDR report key: 1581 · Received October 15, 1992

Report

Report Number
1581
Event Type
Injury
Date Received
October 15, 1992
Date of Event
September 17, 1992
Report Date
October 6, 1992
Manufacturer
HILL-ROM
Product Code
FNL
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

RESIDENT FOUND AT APPROXIMATELY 7:40 A.M. WITH RIGHT LEG CAUGHT IN BEDRAIL. RESIDENT HAD A LACERATION 6CM LONG AND 2CM DEEP LOCATED APPROXIMATELY HALFWAY DOWN RIGHT TIBIA, RESIDENT WAS SENT TO HOSPITAL AND RECEIVED SUTURES. BED WAS INSPECTED BY ADMINISTRATOR, AND FIRE SAFETY CHAIRMAN AND FOUND THAT BEDRAIL HAD WIELDING THAT HAD NOT BEEN PROPERLY GROUND OFF CAUSING INJURY. MANUFACTURER WAS ALSO NOTIFIED OF PROBLEM, ALL BEDS WERE INSPECTED FOR THIS PROBLEM. NO PROBLEMS FOUND, BED THAT INJURY OCCURRED WAS REMOVED FROM FACILITYDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE DISCARDED, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HBR HEALTHCARE CO N/A FNL HILL-ROM 570

Patients

Seq Age Sex Outcome Treatment
1 83 YR Required Intervention