MAUDE Adverse Event Report: HYGENIC CORPORATION THERABAND; EXERCISE BAND

Device Problem Material Integrity Problem (2978)

Patient Problem Damage to Ligament(s) (1952)

Event Date 07/10/2013

Event Type  Injury  

Manufacturer Narrative

Every reasonalbe effort was made to obtain the device.Device was not returned.We are unable to confirm the deivce in question is our product.

Event Description

Patient was doing his daily physical therapy using a new theraband as instructed and prescribed by his personal physician.As he was pulling back the theraband broke and with the force sent his arm back to over a 90 degree angle and caused severe injury to his shoulder.He had to have surgery on his shoulder to repair the injury.The mri showed a complete rip to his shoulder.

Manufacturer Narrative

Every reasonable effort was made to obtain the device.Device was not returned.We are unable to confirm the device in question is our product.Follow up information: insurance claim was closed based on lack of evidence that it was a theraband.

• Brand Name: THERABAND
• Type of Device: EXERCISE BAND
• 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: 5732708
• MDR Text Key: 47646387
• Report Number: 1519375-2016-00002
• Device Sequence Number: 1
• Product Code: ION
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2015
• 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: 45 YR
• Patient Weight: 79