MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. WHEELCHAIR CONTOUR CUSHION

Catalog Number MSCCONPL2418

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 03/16/2015

Event Type  Injury  

Event Description

It was reported that the end user developed two stage ii lesions while sitting on the cushion.

Manufacturer Narrative

It was reported that the end user developed two stage ii pressure ulcers while using this cushion.There was one on each buttock.He was treated with a topical antibacterial ointment with good results.It is unk how often skin assessments were done or how often the end user was repositioned.He has been utilizing this cushion on both a wheelchair and on a recliner since (b)(6) 2013.His nutritional status is unk.The sample was returned and evaluated and no manufacturing defects were found.We cannot confirm that the device caused the reported tissue injury.

• Brand Name: WHEELCHAIR CONTOUR CUSHION
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 4713462
• MDR Text Key: 5660948
• Report Number: 1417592-2015-00033
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MSCCONPL2418
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 109