MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SLINGS, LOOP

Model Number MLA7000-L

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Arjohuntleigh received a complaint where it was indicated that stitching inside of the loops were loose."open loop stitching".No injuries were reported as a consequence of the event."no pt involved.Damage discovered by inspection before use".Reference mfr report #3007420694-2014-00025.

• Brand Name: SLINGS, LOOP
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3723523
• MDR Text Key: 17385533
• Report Number: 1419652-2014-00070
• Device Sequence Number: 1
• Product Code: IKX
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2014,02/14/2014

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
• Device Operator: Other
• Device Model Number: MLA7000-L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2014
• Distributor Facility Aware Date: 02/14/2014
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other