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

Model Number MLA4531-M

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Arjohuntleigh received a complaint where it was indicated that stitching inside of the loops were loose - "stitching has come loose.Customer expresses its concern regarding the quality of stitching." no injuries were reported as a consequence of the event - "no incident reported." ref mfr # 3007420694-2014-00014.

• 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: 3674877
• MDR Text Key: 4257144
• Report Number: 1419652-2014-00047
• Device Sequence Number: 1
• Product Code: IKX
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2014,01/22/2014

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: MLA4531-M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2014
• Distributor Facility Aware Date: 01/22/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/20/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other