MAUDE Adverse Event Report: HYGENIC CORPORATION THERABAND; EXERCISE BAND

Device Problem Material Integrity Problem (2978)

Patient Problem Hip Fracture (2349)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

The incident occurred on (b)(6) 2015 at a physical therapy clinic in (b)(6).At the time the subject incident occurred, she was using 2 exercise bands in an attempt to strengthen her shoulders.One of her shoulders had previously undergone rotator cuff surgery.The other shoulder had a torn rotator cuff but no surgery had been performed.As she was leaning back, one of the bands snapped and she fell to the floor.She landed on her left hip.She felt immediate pain.Although she wasn't being personally supervised, she is fairly confident that the physical therapy staff could see the exercises she was doing and the manner in which she was using the exercise bands.She acknowledged that it was her understanding that it was important to remain balanced while doing physical therapy exercises.However, she denied that anyone ever told her that it was unacceptable to lean back while using the exercise bands.She was taken by ambulance to the hospital where she underwent an open reduction and internal fixation of a left hip fracture.

• 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: 5732690
• MDR Text Key: 47646508
• Report Number: 1519375-2016-00001
• 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
• 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: 10/28/2015
• 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: 99 YR
• Patient Weight: 59