MAUDE Adverse Event Report: PINGHU WEIFENG MATERIAL TECHNOLOGY CAREGUARD TOOL LESS SHOWER CHAIR WITHOUT BACK 2/CARTON 9153645724; ADAPTOR, HYGIENE

Model Number 91-2

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The consumer's daughter alleges that when her mother sits on the 91-2 shower chair, the legs splay out and she goes all the way to the ground.The caller states the screw in the middle where the legs attach to the seat is bent.

• Brand Name: CAREGUARD TOOL LESS SHOWER CHAIR WITHOUT BACK 2/CARTON 9153645724
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): PINGHU WEIFENG MATERIAL TECHNOLOGY; pinghu ; CH
• MDR Report Key: 4495755
• MDR Text Key: 21089820
• Report Number: 1531186-2015-00857
• 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
• Type of Report: Initial
• Report Date: 02/06/2015,02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 91-2
• 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: 02/06/2015
• Distributor Facility Aware Date: 02/02/2015
• Date Report to Manufacturer: 02/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other