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

Model Number NC89189

Device Problem Insufficient Information (3190)

Patient Problems Post Traumatic Wound Infection (2447); Partial thickness (Second Degree) Burn (2694)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

Device discarded by patient.

Event 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
• Type of Device: IONTOPHORESIS PATCH
• Manufacturer (Section D): NORTH COAST MEDICAL, INC.; 8100 camino arroyo; gilroy CA 95020
• Manufacturer Contact: jennifer moffatt ; 8100 camino arroyo; gilroy, CA 95020 ; 4087765000
• MDR Report Key: 6562011
• MDR Text Key: 74989366
• Report Number: 2939821-2017-00001
• Device Sequence Number: 1
• Product Code: EGJ
• UDI-Device Identifier: 00859975005202
• UDI-Public: (01)00859975005202(17)181228(10)BEW161002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR