MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO LTD SHWR COMMODE 23 IN TIRES 18 INW 9153640949; ADAPTOR, HYGIENE

Model Number NA:6895

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

This is a distributed product and this report will be sent to the manufacture, jiangsu yuyue medical equipment & supply co ltd.There is no malfunction or defect alleged.It appears that it is not the correct shower chair for the end user.The end user is an incomplete quad with bilateral amputations of the lower extremities which caused her weight to be distributed more to the top of her body.The weight distribution caused end user to tip backwards.There was no malfunction of the shower chair.The dealer is returning the unit for end user and working with them to find something that will work with their needs.Should additional information become available, a supplemental record will be filed.

Event Description

The caregiver stated that the end-user was using her new 6895 shower chair for the first time, she was leaning back to wet her hair, and the chair flipped backward, and she hit her head and cut her scalp.The caller states the end user was taken to the hospital by ambulance where she received 12 staples in the back of her head.The caller states the end user was released.

Manufacturer Narrative

The 6895 mariner shower commode was returned to invacare for inspection, which was completed on 10/16/2019.Through visual inspection of the device, it was observed that there was no damage to the side frames or cross brace.The seat and backrest were inspected, and it was noted that no damage was present.The drive wheels and casters were also inspected.It was also observed that no damage was present.During functional testing the shower chair was able to maneuver in the forward,right, left and reverse directions without issue.The wheel locks were able to engage, preventing the wheels from rotating, and disengage without issue.Finally, the shower commode was able to fold.

Event Description

The caregiver stated that the end-user was using her new 6895 shower chair for the first time, she was leaning back to wet her hair, and the chair flipped backward, and she hit her head and cut her scalp.The caller states the end user was taken to the hospital by ambulance where she received 12 staples in the back of her head.The caller states the end user was released.

• Brand Name: SHWR COMMODE 23 IN TIRES 18 INW 9153640949
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO LTD; no. 2, zhenxin rd; yunyang ind. park, 212300; danyang, jiangsu
• MDR Report Key: 9145461
• MDR Text Key: 160896389
• Report Number: 1531186-2019-00006
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/27/2019,09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Catalogue Number: 6895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 09/27/2019
• Distributor Facility Aware Date: 09/09/2019
• Device Age: 2 MO
• Date Report to Manufacturer: 09/27/2019
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 82