inforMED
InjuryIOY

INDENT-A-BAND

Received Sep 15, 1992 · Event occurred Aug 20, 1992

Report 1358 · MDR key 1358

Device

Generic name

Unknown

Manufacturer

Hollister

Model number

UNKNOWN

Catalog number

6748

Lot number

UNKNOWN

Patient

97 YR

Narrative

Description of Event or Problem

REPORTED TO NURSE BY NURSE ASSISTANT THAT RESIDENT HAD A SKIN TEAR LOWER RIGHT ARM @ WRIST. APPROX 2.5CM IN LENGTH X 1/16 CM WIDTH CLEANSED W/ HP/2 APPLIED TEGADERM. PLACED ON ALERT CHARTING TO BE CHARTED GSHIFT TIL RESOLVEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.