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

Model Number 2510

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complaint device has been discarded and is not available for evaluation.Therefore, this report is based solely on customer-provided information.The dhr was reviewed and found that lot# 0239t108 passed all production verification before shipping.There were no ncrs associated with this lot.Aside from 2 complaints associated with this report, there have been 5 complaints received in the last 5 years for 2510 breaking while in use with a patient.In all cases, the cause was determined to be user error or a failure to follow the instructions for use (ifu) steps for application of the device, as well as use with the incorrect patient population for this device.Corrective actions implemented included in-service training with the staff at the user facility and updating the ifu to better clarify a step to wrap the strap around the wrist ensuring that the force is applied to the strap rather than the foam.Ifu i9211 rev c was released on sept 21, 2020.It was verified that this lot (0239t108) was manufactured containing i9211 rev b, prior to those updates being implemented.Without the return of the device, the reported issue could not be confirmed.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no further 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.Manufacturing reference file # (b)(4).

Event Description

Customer contacted us easy to rip.Two incidents wherein patient was able to get out of restraints with little effort." lot# 0239t108, no gtin information available.Limited other information was made available by the customer.

• Brand Name: LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 2530 lindsay privado dr; unit a; ontario CA 91761
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 11270448
• MDR Text Key: 250961099
• Report Number: 2020362-2021-00003
• 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: 01/08/2021

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: 2510
• Device Catalogue Number: 2510
• Device Lot Number: 0239T108
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2019
• 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