MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-05 for THERABAND 081457118 564765 manufactured by The Hygenic Corporation.
[76628097]
Patient Sequence No: 1, Text Type: N, H10
[76628098]
The patient was exercising in the outpatient physical therapy gym. She was holding onto a blue thera-tube and sidestepping when it snapped and hit her left hand. The patient was on blood thinners so she developed a small skin tear with bleeding. During activity the thera-tubing gave way due to repetitive usage. This is an item that is on a wall mounted device that is used multiple times. It appears to have worn out and will be replaced with new tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6610491 |
| MDR Report Key | 6610491 |
| Date Received | 2017-06-05 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-05-22 |
| Report Date | 2017-05-30 |
| Date Reported to FDA | 2017-05-30 |
| Date Reported to Mfgr | 2017-05-30 |
| Date Added to Maude | 2017-06-05 |
| 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 |
| Generic Name | EXERCISER, NON-MEASURING |
| Product Code | ION |
| Date Received | 2017-06-05 |
| Model Number | 081457118 |
| Catalog Number | 564765 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE HYGENIC CORPORATION |
| Manufacturer Address | 1245 HOME AVENUE AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-05 |