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U.S. Department of Health and Human Services

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

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POSEY PRODUCTS LLC FOAM LIMB HOLDER RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2532
Device Problem Misassembled (1398)
Patient Problem Extubate (2402)
Event Type  Injury  
Manufacturer Narrative
Evaluation results: evaluation of the returned device found the male buckle component at the bed connecting strap, on a single returned limb holder, was installed backward causing the bed connecting strap to slip when pulled. All buckles were compared to the product drawing and product sample. The male buckle installed incorrectly is a known issue related to documentation guiding the manufacturing process. The issue has been addressed internally via corrective action. Samples taken from multiple lots, at multiple facilities, found no other instances of incorrectly installed male buckles. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warrant. Manufacturer reference file# (b)(4).
 
Event Description
Customer reported that the wrist restraint does not restrain the patient and that they recently had a patient self-extubate. The customer stated that it appears to be that the clip on the unit was installed backwards. The date the issue was discovered is unknown.
 
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Brand NameFOAM LIMB HOLDER
Type of DeviceRESTRAINT, PROTECTIVE
Manufacturer (Section D)
POSEY PRODUCTS LLC
5635 peck rd
arcadia CA 91006
Manufacturer Contact
william hincy
posey products llc
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key8474643
MDR Text Key140654823
Report Number2020362-2019-00064
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2532
Device Catalogue Number2532
Device Lot Number9021T147
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/02/2019 Patient Sequence Number: 1
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