MAUDE Adverse Event Report: PINGHU WEIFENG MATERIAL TECHNOLOGY DAILY ACTIVITY ASSIST DEVICES; 890.5050

Model Number 96-2

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2014

Event Type  No Answer Provided  

Event Description

Dealer reported that the end user was sitting on the (b)(4) shower chair, on a flat surface in the shower, when the metal under the seat, where the legs come together, started to bend in the middle.The legs were set at the highest setting of seven.

• Brand Name: DAILY ACTIVITY ASSIST DEVICES
• Type of Device: 890.5050
• Manufacturer (Section D): PINGHU WEIFENG MATERIAL TECHNOLOGY; pinghu ; CH
• MDR Report Key: 3927550
• MDR Text Key: 4534889
• Report Number: 1531186-2014-02468
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/09/2014,06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 96-2
• 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: 07/09/2014
• Distributor Facility Aware Date: 06/05/2014
• Device Age: 1 YR
• Date Report to Manufacturer: 07/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other