MAUDE Adverse Event Report: JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO LTD SHWR COMMODE 5 IN CASTER 18 INW 9153640951; ADAPTOR, HYGIENE

Model Number NA:6891

Device Problem Break (1069)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

The end user recovered from the fall and has been using a replacement donated unit but preferred the invacare unit.The shower commode was not returned to invacare for evaluation.We requested the unit back and offered to replace it, and she said no it was in excellent condition and just needed the new seat we sent.If more information is received a follow up report will be filed.

Event Description

The consumer alleged the seat came off the back of the 6891-shower commode, and the patient and the chair went forward and hit the floor.The caller stated the consumer had the seat belt on at the time of the incident.The consumer went to the er and received x-rays confirming a dislocated shoulder.The caller stated, the consumer received emergency treatment and was released.The caller states the consumer refuses to send the unit back and only wants a new seat.

• Brand Name: SHWR COMMODE 5 IN CASTER 18 INW 9153640951
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO LTD; yunyang industrial park; danyang, china ; CH
• MDR Report Key: 8794161
• MDR Text Key: 151155980
• Report Number: 1531186-2019-00005
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2019,06/24/2019

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:6891
• Device Catalogue Number: 6891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2019
• Distributor Facility Aware Date: 06/24/2019
• Date Report to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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