INDENT-A-BAND
Received Sep 15, 1992 · Event occurred Aug 20, 1992
Report 1358 · MDR key 1358
Device
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.