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 |