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MAUDE MDR 3640

MDR report key
3640
Report number
3640
Event key
0
Event type
3
Date of event
1992-06-27
Date received
1993-01-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WRIST RESTRAINTTECHNOLKID24442N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11993-01-0101. D

Event Narratives#

D

Patient 1

PATIENT WAS FOUND MOTIONLESS ON THE ASPHALT GROUNDS OF THE HOSPITAL COURTYARD. PATIENT RESUSCITATED UNSUCCESSFULLY IN ER. PATIENT'S BED STILL WITH 4 SIDERAILS UP, UPPER LIMB, LOWER LIMB RESTRAINTS ATTACHED TO BE, LEFT LOWER LIMB RESTRAINT BROKEN, NO WITHNESSES TO ACTUALFALLDEVICE LABELED FOR SINGLE USE. 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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.