MAUDE Adverse Event Report: ARJO MED AB LTD OPERA

Device Problems Unintended Arm Motion (1033); Component Falling (1105)

Patient Problems Sprain (2083); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Imp ref# (b)(4).

Manufacturer Narrative

(b)(4).Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site arjo (b)(4).As of 06/15/2010, that number was de-activated due to the site no longer being a manufacturer.Going forward, complaints related to this product are to be handled by arjohuntleigh magog and any medwatch reports will be submitted.The device was inspected on site by a representative of the manufacturer's sales and service unit subsidiary division, not a direct employee of the manufacturer.Additional information will be provided following the conclusion of the manufacturer's investigation.

• Brand Name: OPERA
• Manufacturer (Section D): ARJO MED AB LTD; st catherine street; gloucester GL1 2SL; UK GL1 2SL
• Manufacturer (Section G): ARJO MED AB LTD; st catherine street; gloucester GL1 2SL; UK GL1 2SL
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3771195
• MDR Text Key: 15322021
• Report Number: 9681684-2014-00007
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2002
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1