MAUDE Adverse Event Report: ACTIVATEK, INC. ACTIVAPATCH IONTOGO 4.0; IONTOPHORESIS PATCH

Model Number 001-50

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 10/19/2015

Event Type  Injury  

Event Description

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.

• Brand Name: ACTIVAPATCH IONTOGO 4.0
• Type of Device: IONTOPHORESIS PATCH
• Manufacturer (Section D): ACTIVATEK, INC.; 8100 camino arroyo; gilroy CA 95020
• Manufacturer Contact: jennifer moffatt ; 8100 camino arroyo; gilroy, CA 95020 ; 8008219319
• MDR Report Key: 5930930
• MDR Text Key: 54024431
• Report Number: 3005917950-2016-00001
• Device Sequence Number: 1
• Product Code: EGJ
• 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: Other
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physical Therapist
• Device Expiration Date: 04/02/2017
• Device Model Number: 001-50
• Device Catalogue Number: NC89189
• Device Lot Number: BEW150102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• 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): Other
• Patient Age: 46 YR
• Patient Weight: 84