inforMED
InjuryFNK

UNKNOWN

Received May 17, 1993 · Event occurred Mar 29, 1993

Report 5177 · MDR key 5177

Device

Generic name

Unknown

Manufacturer

Unknown

Model number

UNKNOWN

Catalog number

UNKNOWN

Lot number

UNKNOWN

Patient

91 YR

Narrative

Description of Event or Problem

RESIDENT WAS FOUND WITH HEAD STUCK IN RIGHT SIDE RAIL ON BED, HAD SCRAPPED AREA 1/2" ON FOREHEAD WITH READ AREA ON NECK. RESIDENT DEVELOPED 4 AND 1/2" BRUISE ON FORHEAD AROUND SCRAPED AREA. SIDE RAILS WERE COVERED WITH FOAM PADDING WITH SHEET WRAPPED AROUND THEM TO PREVENT FURTHER INJURYDEVICE NOT 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: UNKNOWN. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.