MAUDE Adverse Event Report: DJO, LLC PROCARE; SECURE-ALL LIMB HOLDER

Model Number	79-91470
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint received that alleges " "two times lately a vented patient has broken the restraints and one of them self-extubated but the patient was not harmed".Device not returned to manufacturer for evaluation.No indication event caused or contributed to serious injury, permanent impairment or death.

• Brand Name: PROCARE
• Common Device Name: SECURE-ALL LIMB HOLDER
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 5880518
• Report Number: 9616086-2016-00020
• Device Sequence Number: 10885906
• Product Code: FMQ
• UDI-Device Identifier: 00888912038522
• UDI-Public: 00888912038522
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/16/2016

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
• Operator of Device: Health Professional
• Device Model Number: 79-91470
• Device Lot Number: 1032455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2016
• Initial Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other