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

Model Number 2532

Device Problem Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: evaluation of the returned device found the bed connecting strap was threaded incorrectly into the male buckle, and it appears to be stretched or worn.The worn area of the bed connecting strap will slip when pulled at an angle.The issue has been addressed internally via corrective action.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 warranted.Manufacturer reference file# (b)(4).

Event Description

Customer reported the teeth appear to be correct, but the strap is not holding.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: william hincy ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 8491822
• MDR Text Key: 142089106
• Report Number: 2020362-2019-00067
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Device Lot Number: 8347T065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1