MAUDE Adverse Event Report: UNKNOWNN/AN/A N/A

Model Number N/A

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

The end-user was standing up in the shower washing her hair, and when she sat back down on the chair, a small piece of plastic broke on the seat.

Event Description

Received a few more details regarding this event.The event had occurred in the end-user's home on a fiberglass surface material.All rubber feet are reported as having been free of splits, cracks or tears, as well as touching the floor at the time the incident had occurred.The end-user is reported as having not been supervised or assisted at the time the incident had occurred.It is otherwise known that the device was owned, and used for an unknown amount of time.

• Brand Name: N/A
• Type of Device: N/A
• Manufacturer (Section D): UNKNOWNN/AN/A; n/a; n/a; n/a
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: n/a n/a ; n/a; n/a; n/a, OH 44130 ; 8009471728
• MDR Report Key: 5978425
• MDR Text Key: 55670063
• Report Number: 9681423-2016-00015
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

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: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70