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

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Reference importer report (b)(4).

Manufacturer Narrative

(b)(4).Arjohuntleigh received a complaint where it was indicated that stitching inside of the loops became loose.This malfunction was discovered by inspection before use.No pt was involved.No injuries have been reported by the customer.When reviewing similar reportable events, we have found a number of cases with similar fault description (loop stitching inside loop failed).The trend observed for reportable complaints with this failure mode is currently considered to be low and stable and slightly increasing.It has been established that the sling was not being used for pt handling at the time of the event.During our investigation the sling was found with loop stitching inside loop failed and was found to not have been to specification.Tests carried out during the development of the sling, and in current production on every sling manufactured, would indicate the stitching of the loops meets the oem specification.A proper inspection of the sling should have detected the failure of the sling, especially since both attachments points of the yellow loop were broken.From the information received the sling was not being used for treatment or diagnosis of the pt when the failure of the stitching inside loop was found.Therefore, the sling showing signs of un-stitching, should be withdrawn and replaced.Our reports confirm that the sling is not likely to fail during the intended, correct use as described in the instructions for use (ifu), but that a failure can occur during a use error.We find this complaint to be reportable to the competent authorities.

• Brand Name: SLINGS, LOOP
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3723438
• MDR Text Key: 18624118
• Report Number: 3007420694-2014-00025
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1