MAUDE Adverse Event Report: NORTH COAST MEDICAL, INC. ACTIVAPATCH IONTOGO 4.0; IONTOPHORESIS PATCH

Model Number	NC89189
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Wound Infection (2447); Partial thickness (Second Degree) Burn (2694)
Date of Event	03/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded by patient.
Event or Problem Description
Per customer, "utilized ionto patch coupled with dexamethasone at the end of treatment.Skin cleaned with alcohol swab and patch applied without any need for taping, adhered well.Pt instructed to leave patch on 4 hrs.She noted burns after removal." also, patient was "instructed to clean burns (b)(6) 2017 and apply neosporin.Patient followed up with pcp tuesday and is being treated for infection with antibiotics.".

• Brand Name: ACTIVAPATCH IONTOGO 4.0
• Common Device Name: IONTOPHORESIS PATCH
• Manufacturer (Section D): NORTH COAST MEDICAL, INC.; 8100 camino arroyo; gilroy CA 95020
• MDR Report Key: 6562011
• Report Number: 2939821-2017-00001
• Device Sequence Number: 865142
• Product Code: EGJ
• UDI-Device Identifier: 00859975005202
• UDI-Public: (01)00859975005202(17)181228(10)BEW161002
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physical Therapist
• Device Expiration Date: 12/28/2018
• Device Model Number: NC89189
• Device Catalogue Number: NC89189
• Device Lot Number: BEW161002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/11/2017
• 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: Required Intervention
• Patient Age: 16 YR