MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for KT TAPE PRO manufactured by Kt Health, Llc..
[179448165]
Blisters. Wore kt tape x 3 hours on thurs (b)(6) 2020. Removed and showed after practice. The next day the area had extensive blistering. Did the problem stop after the person reduced the dose or stopped taking or using the product? Yes. Quantity: 2 strips. Frequency: daily. How was it taken or used: topical. Date the person started taking or using the product: (b)(6) 2020. Date the person stopped taking or using the product: (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092962 |
| MDR Report Key | 9706262 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-09 |
| Date of Event | 2020-02-07 |
| Date Added to Maude | 2020-02-13 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KT TAPE PRO |
| Generic Name | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2020-02-12 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KT HEALTH, LLC. |
| Product Code | --- |
| Date Received | 2020-02-12 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-12 |