MAUDE Adverse Event Report: POSEY, S. DE R.L. DE C.V. POSEY BLUE FOAM SOFT WRIST RESTRAINT; RESTRAINT, PROTECTIVE

Lot Number 4020T56

Device Problems Material Disintegration (1177); Fail-Safe Problem (2936)

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

Event Date 05/03/2023

Event Type  malfunction  

Event Description

The blue foam soft wrist restraints that were placed on patient "shredded" due to patient pulling, and was found on his skin and bed linens.Reference report mw5117622.

• Brand Name: POSEY BLUE FOAM SOFT WRIST RESTRAINT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY, S. DE R.L. DE C.V.; neenah WI 54956
• MDR Report Key: 16952712
• MDR Text Key: 315579123
• Report Number: MW5117621
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2023

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: Health Professional
• Device Lot Number: 4020T56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White