MAUDE Adverse Event Report: BRODA SEATING BARI 385 BARIATRIC TRANSPORT COMMODE/SHOWER CHAIR BRODA CHAIR; ADAPTOR, HYGIENE

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

Patient Problem Skin Tears (2516)

Event Date 12/01/2017

Event Type  No Answer Provided  

Event Description

Cna providing care after shower while resident was in shower chair.Resident received a dog-eared skin tear from lower extremity coming in contact with shower chair.

• Brand Name: BARI 385 BARIATRIC TRANSPORT COMMODE/SHOWER CHAIR BRODA CHAIR
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): BRODA SEATING
• MDR Report Key: 8722805
• MDR Text Key: 149083028
• Report Number: MW5087515
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Patient Age: 89 YR
• Patient Weight: 56