MAUDE Adverse Event Report: POSEY COMPANY LEATHER LOCKING CUFFS; RESTRAINT, PROTECTIVE

Model Number 2204

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Note: this report is based solely on the customer reported issue.Note: instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states "before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch; cracked or broken buckles or locks; and/or that hook and loop adheres securely, as these may allow patient to remove cuff.Discard if device is damaged." (b)(4) pending product receipt.

Event Description

Customer reported a patient was able to rip apart a connection from a set of maximum security restraints.Customer alleges that there is a weak point where the rivets connect the strap to the actual restraint.The date the issue was discovered is unknown and no patient injuries were reported.

Manufacturer Narrative

Numerous attempts were made to get the product back, but the customer reported that the device will not be returned because it was discarded.The customer reported that the restraint appeared to have been cut with a sharp object and the device did not malfunction.The customer reported that this particular restraint was being used on a very large, strong young man who was very unwell and extremely uncooperative.The hospital staff witness the patient cause the reported damage.There is no evidence to suggest that a manufacturing non-conformity contributed to the event.The instructions for use state "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.Be aware that a sudden mood swing may cause agitated or aggressive behavior.Contact the medical team at once if this occurs.No level of monitoring may avoid the risk of serious injury to highly agitated or aggressive patients." manufacturing reference file # (b)(4).

Event Description

Supplemental is required for additional event information.

• Brand Name: LEATHER LOCKING CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY COMPANY; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6571198
• MDR Text Key: 75422933
• Report Number: 2020362-2017-00017
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 2204
• Device Catalogue Number: 2204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2017
• 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