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U.S. Department of Health and Human Services

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

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POSEY COMPANY LEATHER LOCKING CUFFS RESTRAINT, PROTECTIVE Back to Search Results
Model Number 2204
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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.
 
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.
 
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Brand NameLEATHER LOCKING CUFFS
Type of DeviceRESTRAINT, 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 Key6571198
MDR Text Key161754685
Report Number2020362-2017-00017
Device Sequence Number1
Product Code FMQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Model Number2204
Device Catalogue Number2204
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2017
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 Unkown

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