MAUDE Adverse Event Report: HYGENIC CORPORATION THERABAND; STANDARD EXERCISE BALL

Device Problem Material Rupture (1546)

Patient Problem Rupture (2208)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

Report is under investigation.Have not confirmed this to be a hygenic product at this time.Product has not been returned.

Event Description

On (b)(6) 2015 patient had an incident in which a theraband standard ball malfunctioned and collapsed.This malfunction caused severe orthopedic injuries including a ruptured disc.The injuries will require surgery.We do not know which standard ball this was.

• Brand Name: THERABAND
• Type of Device: STANDARD EXERCISE BALL
• Manufacturer (Section D): HYGENIC CORPORATION; 1245 home ave.; akron OH 44310
• Manufacturer (Section G): HYGENIC CORPORATION; 1245 home ave.; akron OH 44310
• Manufacturer Contact: lisa piero ; 1245 home ave; akron, OH 44310 ; 3306342238
• MDR Report Key: 5811682
• MDR Text Key: 50076932
• Report Number: 1519375-2016-00005
• Device Sequence Number: 1
• Product Code: ION
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 99 YR
• Patient Weight: 79