MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-06 for ACTIVAPATCH INTELLIDOSE 2.5 001-40 NC89188 manufactured by Activatek, Inc..
[54021111]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[54021112]
Patch was removed from pouch; pull tab was removed activating the patch. Patient's skin was inspected and found to be intact. During initial examination of the area, sensation to crude light touch was noted to be intact. Treatment area was wiped clean with the provided alcohol wipe and allowed to thoroughly air dry. Utilizing a marked syringe, 2. 0 cc of acetic acid was drawn and then used to hydrate the active ionic solution reservoir. No dry spots on the pad were observed. The liner was peeled from the patch; the patch was placed directly on the treatment area. The remaining release liner over the pull tab was removed. The flash sequence was observed, compared to the flash sequence chart provided and found to be one flash/30 sec, indicating "low skin resistance, treatment started. " patient reported some initial stinging and burning sensations and was instructed to remove patch if those feelings persisted. By the time the patient left the clinic, 5 minutes later, she reported that the burning and stinging had decreased; she left with the patch in place; i emphasized again that if any further burning continued, she was to remove the patch immediately and wash the area with warm soapy water. On (b)(6) 2016, the patient phoned the clinic. I spoke to her and she told me that she had gone out to dinner the prior evening after leaving the clinic. She had set an alarm to alert her when the 2. 5 hours had passed. When the alarm sounded, she had difficulty removing the patch. The patient reported that she had experienced no discomfort while wearing the patch. The initial burning and stinging had lasted only a short period, then she felt nothing. She said there appeared to be a residual film on her skin and that it had a black and green appearance. I told her i suspected it may be clothing fibers clinging to any residual adhesive and asked her to come in to the clinic so i could see it. When the patient arrived, i observed a 4 cm height, 5 cm width round area of black tissue, which i photographed. I phoned her physician's office and arranged for her to be seen urgently that afternoon. I spoke with her physician after he saw her; he informed me the patient has a 4. 5 cm full thickness burn, which will need to be debrided and surgically closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005917950-2016-00002 |
| MDR Report Key | 5931376 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-06 |
| Date of Report | 2016-05-11 |
| Date of Event | 2016-05-10 |
| Date Mfgr Received | 2016-05-11 |
| Device Manufacturer Date | 2014-06-01 |
| 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 | 0 |
| 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 | 3 |
| Brand Name | ACTIVAPATCH INTELLIDOSE 2.5 |
| Generic Name | IONTOPHORESIS PATCH |
| Product Code | EGJ |
| Date Received | 2016-09-06 |
| Model Number | 001-40 |
| Catalog Number | NC89188 |
| Lot Number | BEW140401 |
| Device Expiration Date | 2016-05-31 |
| 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 |