MAUDE Adverse Event Report: UNKNOWN ALL-IN-ONE COMMODE (COATED) 9153629773; ADAPTOR, HYGIENE

Model Number 9630-4

Device Problem Crack (1135)

Patient Problems Burning Sensation (2146); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

This product was manufactured by invacare at either invamex or aquatec (b)(4) and invacare has chosen to file this report utilizing the aquatec (b)(4) cfn/fei registration.

Event Description

The wife of the end user reported that the seat on her husband's 9630-4 commode has cracked the length of the seam on the underside of the seat.The user sustained scratches along with a pinch on his right thigh which is causing a burning sensation.No alleged medical intervention.

Manufacturer Narrative

The commode seat has been returned & evaluated by invacare.It was observed that the crack went all the way through the right side of the commode seat material such that it was visible on the seat underside, and there was clear adhesive holding the crack together on the top side and underside of the seat.The crack measured roughly 8" in length, the left side of the seat was intact.The cracking damage followed the line pattern of the plastic molding on the underside of the seat.There was no identifying product label present on the item, therefore the manufacturer and the date code, which would indicate the age of the seat, are unknown.However, there was a design change for the commode seat that was implemented on 04/24/2013, therefore, indicating that the age of the commode seat is 3 years 6 months, well past the expected life of 1 year.Upon further review it has been determined that should the malfunction recur, the device would not be likely to cause or contribute to a death or serious injury. .

Event Description

The wife of the end user reported that the seat on her husband's 9630-4 commode has cracked the length of the seam on the underside of the seat.The user sustained scratches along with a pinch on his right thigh which is causing a burning sensation.No alleged medical intervention.

• Brand Name: ALL-IN-ONE COMMODE (COATED) 9153629773
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5993017
• MDR Text Key: 56799763
• Report Number: 3007231105-2016-00111
• Device Sequence Number: 1
• Product Code: INN
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9630-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• 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 Weight: 82