InjuryJCA

SIMPLATE II

Received Jul 31, 1992 · Event occurred Apr 22, 1992

Report 4182 · MDR key 4182

Device

Generic name

Bleeding Time Device

Manufacturer

Organon Teknita Corporation

Model number

UNKNOWN

Catalog number

286-618

Lot number

100853

Narrative

Description of Event or Problem

ON APRIL 22, 1992, USE OF IMPLATE LEFT TWO GAPING WOUNDS RSTHER THAN SMALL INCISIONSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.