MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MINSTREL (INCL. MINERVA); NONE

Model Number HMA0001-UK

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2014

Event Type  No Answer Provided  

Event Description

Arjohuntleigh received a complaint where it was indicated that stitching inside of the loops became loose and failed during use.No injuries have been reported by the customer.It was not clearly determine which sling was involved in the incident.In accordance to info provided by the facility two slings were found with loop stitching inside loop failed.The serial numbers of these slings (one of these slings was involved in the incident) are: (b)(4) (loop sling, size l) and (b)(4) (loop sling, size m).It was indicated by the facility that these slings were purchased in (b)(4) 2013.The product was initially inspected by an arjohuntleigh representative confirming the reported failure.Ref mfr #3007420694-2014-00012.

• Brand Name: MINSTREL (INCL. MINERVA)
• Type of Device: NONE
• 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: 3659346
• MDR Text Key: 4197182
• Report Number: 1419652-2014-00041
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2014,01/15/2014

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: Health Professional
• Device Model Number: HMA0001-UK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2014
• Distributor Facility Aware Date: 01/15/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other