MAUDE Adverse Event Report: POSEY PRODUCT UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF; RESTRAINT, PROTECTIVE

Model Number 2700Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This report is based solely on the customer¿s allegation that resulted in a serious injury.Product manager (b)(6) of posey products was able to visit the customers facility and confirm no damages to the product and the unit functioned as designed.Customer confirmed patient was very agitated and in a combative state.The ifu states do not use this device on a patient who is or becomes: suicidal, highly aggressive or combative, self-destructive, or deemed to be an immediate risk to others, unless the patient is under constant supervision.At this time, there is no evidence that a manufacturing nonconformity 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.As a precaution, an internal investigation was initiated to investigate this issue further, assess risk, and determine next steps.Manufacturer reference file (b)(4).

Event Description

Tm reported via email incidents regarding the cuff.Newly purchased product in february 2021, 50 sets.No signs of defect or damage.Security officer was injured during an incident, limited details provided.Troubleshooting guide saved, no gtin.

• Brand Name: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCT; 2530 lindsay privado drive; unit a; ontario CA 91761
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 12197784
• MDR Text Key: 262492907
• Report Number: 2020362-2021-00041
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2700Q
• Device Catalogue Number: 2700Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1