MAUDE Adverse Event Report: INVACARE TAYLOR ST SHWR COMMODE 23 IN TIRES 18 INW 9153640949; ADAPTOR, HYGIENE

Model Number NA:6895

Device Problems Crack (1135); Sharp Edges (4013)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

This issue is being reported in an abundance of caution due to the allegation the device contributed to pressure sores that required ointment, gauze, and instructions on how to keep off the sore area.It is unknown if the medication was otc or rx.The underlying cause of the seat being sharp/cracked couldn't be determined.The end user stated they continued to use the device after noticing the cracks.The age and maintenance history of the device could not be determined.The device has been supplied to invacare by multiple suppliers.Due to unknown serial/lot number the supplier could not be determined for this distributed device, therefore invacare (b)(4) was used as the manufacturing location.Multiple attempts were made to obtain clarification, identifying information, and a return of the device without success.

Event Description

The 6895 shower chair seat has sharp edges and is cracking.The user states they are developing pressure injuries due to the damage and length of time it is taking to acquire a new seat.

• Brand Name: SHWR COMMODE 23 IN TIRES 18 INW 9153640949
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE TAYLOR ST; 1200 taylor st; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor st.; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 15445697
• MDR Text Key: 300133556
• Report Number: 1525712-2022-00008
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:6895
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention