MAUDE Adverse Event Report: JAN MAO BARIATRIC SHOWER CHAIR W/BACK 2/CARTON 9153644274; ADAPTOR, HYGIENE

Model Number 9785-2

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It has been reported by the end user's husband that both rubber bottom pieces of the legs on a 9785-2 shower chair are cracked and falling off.

• Brand Name: BARIATRIC SHOWER CHAIR W/BACK 2/CARTON 9153644274
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): JAN MAO; huizhou ; CH
• MDR Report Key: 4353026
• MDR Text Key: 18729154
• Report Number: 1531186-2014-06742
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/22/2014,11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9785-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2014
• Distributor Facility Aware Date: 11/07/2014
• Device Age: 21 MO
• Date Report to Manufacturer: 12/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization