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

Model Number 2533

Device Problems Defective Component (2292); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states to before each use, check cuff s and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.The ifu also provided extra warning to not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.Without return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed.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 provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative 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.Manufacturer reference file (b)(4).

Event Description

Hca contacted via email regarding item 2533 not functioning properly and allowing the possibility of patient removal.The lot number pull up an hca order from wichita (so l48500 referenced in emails), but the address provided is different (another hca location).Th provided location was not used on patients, while wichita noticed the issue in use(unknown the severity of incident, no injury).Photos provided, official quantity unknown.Troubleshooting guide saved.No gtin number provided.Requesting quantities back, new samples were delivered per customer request (unknown order number) the date the issue was discovered is unknown and no patient incident or injury was reported.

Event Description

Supplemental report needed for additional information.

Manufacturer Narrative

Evaluation found that the product orientation on one of the connecting bed male buckles is sewn incorrectly.In this incorrect orientation, the buckle will not secure the webbing properly allowing more movement when pulled.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 warrant.Manufacturer reference file (b)(4).

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCT; 2530 lindsay privado drive; unit a; ontario CA 91761
• MDR Report Key: 11865527
• MDR Text Key: 264085324
• Report Number: 2020362-2021-00023
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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: 2533
• Device Catalogue Number: 2533
• Device Lot Number: 0302T396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1