MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-06-17 for THERABAND manufactured by Hygenic Corporation.
[47646508]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[47646509]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519375-2016-00001 |
| MDR Report Key | 5732690 |
| Report Source | CONSUMER |
| Date Received | 2016-06-17 |
| Date of Report | 2016-06-16 |
| Date of Event | 2015-09-21 |
| Date Mfgr Received | 2015-10-28 |
| Date Added to Maude | 2016-06-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA PIERO |
| Manufacturer Street | 1245 HOME AVE |
| Manufacturer City | AKRON OH 44310 |
| Manufacturer Country | US |
| Manufacturer Postal | 44310 |
| Manufacturer Phone | 3306342238 |
| Manufacturer G1 | HYGENIC CORPORATION |
| Manufacturer Street | 1245 HOME AVE |
| Manufacturer City | AKRON OH 44310 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44310 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABAND |
| Generic Name | EXERCISE BAND |
| Product Code | ION |
| Date Received | 2016-06-17 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGENIC CORPORATION |
| Manufacturer Address | 1245 HOME AVE AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-17 |