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

Model Number 2510

Device Problem Break (1069)

Patient Problem Extubate (2402)

Event Type  malfunction  

Manufacturer Narrative

Evaluation results.Visual findings observed that the white hook is torn at the box stitch.The d-ring has been pulled excessively as the butt welded joint has come apart creating a gap leading the d-ring to be separated from the foam cuff.The bed connecting strap has multiple creases indicating excessive force was applied.There is no evidence observed of any workmanship issue, and it appears that the product was applied properly.The box stitches joining the foam, wash label, and webbing remained intact and did not fail, but the failures of the product were in the d-ring and white hook.It appears that excessive force was applied by the patient causing the d-ring and white hook to come apart.The reporter at the user facility was contacted directly for more information surrounding the event.It was disclosed that the device was being used with a patient who displayed continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self, which is a contraindication for this device per the product instructions for use (ifu).This user facility has a history of using these devises with the incorrect patient population per the ifu, as well as incorrect application of the device.However, in this case it appears that the device was applied correctly.The company has been in continuous contact with the user facility over the last year to ensure that they have the support needed to prevent any further adverse events occurring at the facility related to the use of our devices.We have communicated our findings that the reported malfunctions are stemming from a failure to follow the product instructions for use, including not being used on the correct patient population and stated our belief that the correction of this misuse is an urgent matter.We have provided them with options of other potential products that would be better suited for use with their patient population, and offered to perform a virtual product review to answer any questions they may have.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.No corrective or preventative actions are necessary at this time.Manufacturer reference file 2021-00064.

Event Description

Customer contacted us via e-mail.Customer states this male patient with chronic cognitive impairment was admitted with severe sepsis of unclear source and altered mental status was admitted evening shift.Patient acutely confused and extremely restless and not sleeping at all.Initially in a roll vest and soft bilateral wrist restraints were placed on the patient as patient constantly attempting to get out of bed and pulling at lines.Patient ripped through wrist restraint and pulled out iv.Torn restraint was removed and replaced with a new one.Ripped restraint given to manager.Customer goes on to state that the problem that the use had was a device malfunction - that is, the device did not do what it was supposed to do.No lot# or gtin information was available.

• Brand Name: ECONOMY 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: 11334255
• MDR Text Key: 250958712
• Report Number: 2020362-2021-00005
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2510
• Device Catalogue Number: 2510
• Device Lot Number: 0097T109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 113