MAUDE Adverse Event Report: HANDICARE USA CEILING LIFT SLING; PATINET SLING

Device Problem Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Refer to user report # (b)(4).

• Brand Name: CEILING LIFT SLING
• Type of Device: PATINET SLING
• Manufacturer (Section D): HANDICARE USA; 10888 metro court; maryland heights 63043
• Manufacturer (Section G): HANDICARE USA; 10888 metro court; maryland heights 63043
• Manufacturer Contact: rekha janarthanan ; 10888 metro court; maryland heights 63043 ; 3142198682
• MDR Report Key: 8162051
• MDR Text Key: 130481445
• Report Number: 3007802293-2018-00050
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2018,12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2018
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1