CANDO INFLATABLE DELUXE ABS EXERCISE BALL 30-1853 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-16 for CANDO INFLATABLE DELUXE ABS EXERCISE BALL 30-1853 * manufactured by Chattanooga Group.

Event Text Entries

[2716042] Patient was sitting on an exercise ball with the therapist behind him holding on to gait belt when the ball popped without warning. The therapist was able to hold the patient in near standing position as a technician brought his wheelchair and the patient was lowered to the chair without injury. The patient was able to complete his physical therapy treatment session without complaints. He denied pain and was within the weight limits for the ball. The therapy ball was inflated by therapy staff to specified diameter as per manufacturer instructions. There was no indication prior to the event that the ball would burst. The ball is supposed to slowly deflate rather than burst or pop. In this case, the ball burst and did not slowly deflate--it was rapid deflation. The ball has a large v shape wedge opening in it with smooth edges, approximately 24" x16". The opening is located on the top of the ball, on the opposite side of the inflation port. Staff in this area are very familiar with this product and have not had this experience before. They have contacted the manufacturer and are exchanging out the product. ======================manufacturer response for exercise therapy ball, can-do inflatable deluxe abs exercise ball (per site reporter)======================the manufacturer's representative was notified of the event by staff on the day it occurred. The representative instructed staff that the affected device was not needed and could be discarded. The product currently in use is being replaced with the new product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2579091
• MDR Report Key: 2579091
• Date Received: 2012-05-16
• Date of Report: 2012-05-16
• Date of Event: 2012-05-02
• Report Date: 2012-05-16
• Date Reported to FDA: 2012-05-16
• Date Added to Maude: 2012-05-17
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CANDO INFLATABLE DELUXE ABS EXERCISE BALL
• Generic Name: EXERCISE THERAPY BALL
• Product Code: ION
• Date Received: 2012-05-16
• Model Number: 30-1853
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHATTANOOGA GROUP
• Manufacturer Address: 6607 MOUNTAIN VIEW ROAD COLLEGE DALE TN 37363 US 37363

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-05-16