MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-04 for ACTIVAPATCH LONTOGO 4.0 manufactured by Activatek, Inc..
[61616563]
I received multiple burns by the activapatch lontogo 4. 0 on (b)(6) 2016 that have not yet healed. Not sure how it happened, when i removed the patch the burns were present. I had used the exact same product previously without incident but for some reason (probably defective product) i was burned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066546 |
| MDR Report Key | 6147521 |
| Date Received | 2016-12-04 |
| Date of Report | 2016-12-04 |
| Date of Event | 2016-10-13 |
| Date Added to Maude | 2016-12-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | ACTIVAPATCH LONTOGO 4.0 |
| Generic Name | ACTIVAPATCH |
| Product Code | EGJ |
| Date Received | 2016-12-04 |
| Lot Number | BEW150102 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACTIVATEK, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-04 |