MAUDE Adverse Event Report: MEDCARE MEDCARE PT MOVING SLING

Model Number RFLO-0023, RFLO-0043, RBAR-0002

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

In (b)(6) we noticed issues with the integrity of our pt, moving slings.We pulled approx 59 of them from service and called the company to get replacements.Due to shrinkage during laundering the fabric near the end pieces/tabs thinned and the fabric became weak.We have a photo.Main issue is that the fabric in these safe pt moving slings wears out after several washings, heat of dryer and use of bleach which is needed to properly clean them.

• Brand Name: MEDCARE PT MOVING SLING
• Type of Device: MEDCARE PT MOVING SLING
• Manufacturer (Section D): MEDCARE
• MDR Report Key: 6409089
• MDR Text Key: 70268356
• Report Number: MW5068462
• Device Sequence Number: 1
• Product Code: ILI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFLO-0023, RFLO-0043, RBAR-0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1