MAUDE Adverse Event Report: HYGENIC CORPORATION THERABAND; EXERCISE BAND

Device Problem Material Integrity Problem (2978)

Patient Problems Eye Injury (1845); Injury (2348)

Event Date 10/15/2014

Event Type  Injury  

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.

Event Description

He was at pt session where he was performing exercises with a theraband.The band broke and struck him in the eyes and face causing severe pain, injuries to face & eyes, & injury to left 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: it has been confirmed that this was not a hygenic product.

• 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: 5732709
• MDR Text Key: 47645852
• Report Number: 1519375-2016-00003
• 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
• 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
• Date Manufacturer Received: 11/12/2015
• 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): Other
• Patient Age: 45 YR
• Patient Weight: 79