MAUDE Adverse Event Report: UNKNOWN SUCTION CUP GRAB BAR 9153651508; ADAPTOR, HYGIENE

Model Number 218-3

Device Problem Component Falling (1105)

Patient Problems Fall (1848); Injury (2348)

Event Date 11/03/2014

Event Type  Injury  

Event Description

It has been reported by an end user that when getting out of the tub, the grab bar came off the wall causing her to fall back into the tub.She states she hurt her backside.No report of medical attention being sought.

• Brand Name: SUCTION CUP GRAB BAR 9153651508
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4353113
• MDR Text Key: 5219386
• Report Number: 1531186-2014-06612
• 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: 12/18/2014,11/05/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 218-3
• 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: 12/18/2014
• Distributor Facility Aware Date: 11/05/2014
• Date Report to Manufacturer: 12/18/2014
• 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): Other