MAUDE Adverse Event Report: ACTIVATEK, INC. ACTIVAPATCH INTELLIDOSE 2.5; IONTOPHORESIS PATCH

Model Number	001-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	05/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
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.

• Brand Name: ACTIVAPATCH INTELLIDOSE 2.5
• Common Device Name: IONTOPHORESIS PATCH
• Manufacturer (Section D): ACTIVATEK, INC.; 8100 camino arroyo; gilroy CA 95020
• MDR Report Key: 5931376
• Report Number: 3005917950-2016-00002
• Device Sequence Number: 10326087
• Product Code: EGJ
• UDI-Device Identifier: 00859975005219
• UDI-Public: (01)00859975005219
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physical Therapist
• Device Expiration Date: 05/31/2016
• Device Model Number: 001-40
• Device Catalogue Number: NC89188
• Device Lot Number: BEW140401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2016
• Initial Report FDA Received Date: 09/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR