MAUDE Adverse Event Report: THE COMFORT COMPANIES, L.L.C. PERMOBIL® TRU-SHAPE¿

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested regarding the severity of the alleged injury and treatment required.At this time, no responses have been received from the end user.Evaluation of the device history indicates that the remake was built to order specifications, but size requested by end user was two inches too large in width.An injury allegation was submitted; however, medical records are not accessible to confirm.If additional information is received, a follow-up report will be submitted.

Event Description

Per atp (assistive technology professional)- we ordered two molds all off the same file, and they keep coming in different.The one for his pwc keeps coming in wider than the other, and now he has developed skin breakdown.

• Brand Name: PERMOBIL® TRU-SHAPE¿
• Type of Device: TRU-SHAPE
• Manufacturer (Section D): THE COMFORT COMPANIES, L.L.C.; 1930 s. calhoun drive; new berlin, wi WI 53151
• Manufacturer (Section G): THE COMFORT COMPANIES, L.L.C.; 1930 s. calhoun drive; new berlin, wi WI 53151
• Manufacturer Contact: dan wells ; 1930 s. calhoun drive; new berlin, wi, WI 53151 ; 2629097131
• MDR Report Key: 8773364
• MDR Text Key: 150533460
• Report Number: 2135139-2019-00001
• Device Sequence Number: 1
• Product Code: IMP
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other