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

Catalog Number 2510

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2019

Event Type  malfunction  

Event Description

Patient was in the pre-induction room awaiting surgery.Patient with known aggressive behavior was placed in four point restraints for patient and staff safety after attempting to kick several of the staff and removing lines/foley catheter.Lower extremity restraints were rechecked after 15 minutes of application and the left lower restraint was noted to be torn from the backing.The posey restraints are a fairly new product replacement at our facility and are deemed to be inferior to the previous product that utilized synthetic lamb wool.An old pair of synthetic lamb's wool soft restraints were obtained and placed on this patient and these restraints maintained their integrity for the duration of care until the patient was ready for surgery.Staff members have complained of the defects in the new product since it was introduced to our facility.Defects include a leash that is less compliant and therefore more prone to slipping even when a double half-hitch knot is used, and a tendency for the leash to tear off the backing resulting in increased risk of harm and/or skin breakdown for patients.

• Brand Name: LIMB HOLDERS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck rd; arcadia CA 91006
• MDR Report Key: 8980000
• MDR Text Key: 157104668
• Report Number: 8980000
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA