MAUDE MDR 4358

MDR report key
4358
Report number
4358
Event key
0
Event type
3
Date of event
1992-04-19
Date received
1992-07-06
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
1POSEY SHOULD VESTS-VEST RESTRAINTPOSEY COMPANYKID3705H 169370514NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-07-0601. O

Event Narratives#

D

Patient 1

RESIDENT WAS SLIDING OUT OF HER WHEELCHAIR. S-VEST RESTRAINT WAS TIGHT AGAINST HER NECK. RESIDENT;S FACE AND HANDS WERE PURPLE. THE RESTRAINT HAD TO BE CUT TO REMOVE IT FROM THE RESIDENT. THE RESTRAINT WAS APPLIED INCORRECTLY AND THE RESIDENT WAS IN A RAYON FABRIC HOYER SLING WHICH CONTRIBUTED TO HER SLIDING DOWN IN THE WHEELCHAIR. THE PREVENT REOCCURRENCE, STAFF WAS INSERVICED RE: CORRECT APPLICATION OF THE RESTRATINT. ADDITIONALLY, A NON-SKID PAD WILL BE UTILIZED IN THE WHEELCHAIR AND MESH FABRIC HOYER SLING TO PRENENT SLIPPING.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, NONE OR UNKNOWN, OTHER, MISAPPLICATION OF DEVICE. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP, THERE WAS NO DEVICE FAILURE, USER ERROR CAUSED EVENT, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS DESTROYED/DISPOSED OF.