MAUDE Adverse Event Report: POSEY PRODUCT CONNECTED TWICE-AS-TOUGH CUFFS; RESTRAINT, PROTECTIVE

Model Number 2794

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: this report is based solely on the information provided by the customer.Due to product not being returned, confirmation of customer's complaint, and the root cause could not be determined.A review of manufacturing documentation could not be performed since there was no serial/lot number provided for this device.Historical complaint data review revealed similar complaints against a related product.Either product was not returned or the unit that was returned, was found to meet specifications, and function as intended.No other abnormalities or discrepancies were found.The instructions for use were reviewed and determined to provide adequate instructions, and warnings for the safe, and effective use of the device.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 file number: 2020-00636.

Event Description

Jay andrews reported via email two patients were able to loosen the d-rings for item 2794.Limited information provided.No gtin number provided, troubleshooting guide saved.The date the issue was discovered is unknown, no patient incident, or injury was reported.

• Brand Name: CONNECTED TWICE-AS-TOUGH CUFFS
• 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: 10759080
• MDR Text Key: 214174691
• Report Number: 2020362-2020-00120
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2794
• Device Catalogue Number: 2794
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• 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