MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-06 for ACTIVAPATCH IONTOGO 4.0 001-50 NC89189 manufactured by Activatek, Inc..
[54024431]
Per customer, iontogo 4. 0 left a black marking on patient's skin on negative side of patch. Black marking then blistered up and left an open wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005917950-2016-00001 |
| MDR Report Key | 5930930 |
| Date Received | 2016-09-06 |
| Date of Report | 2015-10-21 |
| Date of Event | 2015-10-19 |
| Date Mfgr Received | 2015-10-21 |
| Device Manufacturer Date | 2015-05-18 |
| Date Added to Maude | 2016-09-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. JENNIFER MOFFATT |
| Manufacturer Street | 8100 CAMINO ARROYO |
| Manufacturer City | GILROY CA 95020 |
| Manufacturer Country | US |
| Manufacturer Postal | 95020 |
| Manufacturer Phone | 8008219319 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACTIVAPATCH IONTOGO 4.0 |
| Generic Name | IONTOPHORESIS PATCH |
| Product Code | EGJ |
| Date Received | 2016-09-06 |
| Model Number | 001-50 |
| Catalog Number | NC89189 |
| Lot Number | BEW150102 |
| Device Expiration Date | 2017-04-02 |
| Operator | PHYSICAL THERAPIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACTIVATEK, INC. |
| Manufacturer Address | 8100 CAMINO ARROYO GILROY CA 95020 US 95020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-06 |