FDA Adverse Event
Injury
Summary report: N
ACTIVAPATCH LONTOGO 4.0
MDR report key: 6147521
·
Received December 4, 2016
Report
- Report Number
- MW5066546
- Event Type
- Injury
- Date Received
- December 4, 2016
- Date of Event
- October 13, 2016
- Report Date
- December 4, 2016
- Manufacturer
- ACTIVATEK, INC.
- Product Code
- EGJ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 794526 | ACTIVAPATCH LONTOGO 4.0 | ACTIVAPATCH | EGJ | ACTIVATEK, INC. | BEW150102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other | OTC MEDS: VITAMINS| RX MEDS: BP |