MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for THERABAND ELASTIC RESISTANCE BAND 716802 manufactured by The Hygenic Corporation.
[77420651]
Patient Sequence No: 1, Text Type: N, H10
[77420652]
The patient had a velcro strap headband secured around her head, the theraband was tied to the band at an attachment point. The band was secured around a pole on the other end. The patient was facing the pole and was instructed to step backwards to increase tension on the band while maintaining proper head posture. The band snapped in the mid-section. The end still attached to the headband hit the patient in the right side of her face, just below her eye. A small 1 inch area below her right eye was reddened. No edema or raised pocket of fluid, only skin irritation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6636343 |
| MDR Report Key | 6636343 |
| Date Received | 2017-06-13 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-05-15 |
| Report Date | 2017-06-06 |
| Date Reported to FDA | 2017-06-06 |
| Date Reported to Mfgr | 2017-06-06 |
| Date Added to Maude | 2017-06-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABAND ELASTIC RESISTANCE BAND |
| Generic Name | NON-MEASURING EXERCISER |
| Product Code | ION |
| Date Received | 2017-06-13 |
| Catalog Number | 716802 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE HYGENIC CORPORATION |
| Manufacturer Address | 1245 HOME AVE. AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-13 |