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

Model Number 2530

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned, but has not been received by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.If the strap does not stay secured or is ripped or torn, it could allow unintentional patient release.This could result in the patient injuring self or others.A review of records found that the most recent material configuration change for the webbing material used in this product was processed in june of 2018.No other complaints regarding the quality of this material have been received since then.A review of complaint data found no other complaints received for this part number in the last 5 years.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provided adequate instructions and warning for the safe and effective use of the device.Therefore, no corrective or preventive actions are necessary.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.(b)(4).

Event Description

Customer is getting complaints that the straps on product # 2530 seem to be made out of different materials.The new observed material the customer states is very stiff.The customer says the quick release tie is easier to release with this new materials as compared to the previous materials.The date the issue was discovered is unknown and no injury was reported.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS, LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 6264433143
• MDR Report Key: 9654817
• MDR Text Key: 200200964
• Report Number: 2020362-2020-00002
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2530
• Device Catalogue Number: 2530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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