MAUDE Adverse Event Report: N/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 08/15/2016

Event Type  malfunction  

Event Description

Customer called to report that her chair is rusting and one of the legs broke off.The device is reported as being used in an end-user's home on a fiberglass surface.All four legs/leg tips are reported as touching the floor at the time the incident occurred.

Event Description

Device was returned to manufacturer, and inspected on 9/15/2016.

• Brand Name: N/A
• Type of Device: N/A
• Manufacturer (Section D): N/A; n/a; n/a; n/a, n/a B3B 1 M2; CA B3B 1M2
• Manufacturer (Section G): N/A; n/a; n/a; n/a, n/a B3B 1 M2; CA B3B 1M2
• Manufacturer Contact: n/a n/a ; n/a; n/a, OH 44130 ; 8009471728
• MDR Report Key: 5925647
• MDR Text Key: 53846304
• Report Number: 9681423-2016-00009
• 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: 10/10/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other