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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS LLC LIMB HOLDERS RESTRAINT, PROTECTIVE

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POSEY PRODUCTS LLC LIMB HOLDERS RESTRAINT, PROTECTIVE Back to Search Results
Catalog Number 2510
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2019
Event Type  malfunction  
Event Description
Patient was in the pre-induction room awaiting surgery. Patient with known aggressive behavior was placed in four point restraints for patient and staff safety after attempting to kick several of the staff and removing lines/foley catheter. Lower extremity restraints were rechecked after 15 minutes of application and the left lower restraint was noted to be torn from the backing. The posey restraints are a fairly new product replacement at our facility and are deemed to be inferior to the previous product that utilized synthetic lamb wool. An old pair of synthetic lamb's wool soft restraints were obtained and placed on this patient and these restraints maintained their integrity for the duration of care until the patient was ready for surgery. Staff members have complained of the defects in the new product since it was introduced to our facility. Defects include a leash that is less compliant and therefore more prone to slipping even when a double half-hitch knot is used, and a tendency for the leash to tear off the backing resulting in increased risk of harm and/or skin breakdown for patients.
 
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Brand NameLIMB HOLDERS
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
5635 peck rd
arcadia CA 91006
MDR Report Key8980000
MDR Text Key157104668
Report Number8980000
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2510
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/28/2019
Event Location Hospital
Date Report to Manufacturer09/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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