MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-05-11 for ACTIVAPATCH IONTOGO 4.0 NC89189 manufactured by North Coast Medical, Inc..
[74989366]
Device discarded by patient.
Patient Sequence No: 1, Text Type: N, H10
[74989367]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939821-2017-00001 |
| MDR Report Key | 6562011 |
| Report Source | USER FACILITY |
| Date Received | 2017-05-11 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-03-31 |
| Date Mfgr Received | 2017-04-11 |
| Device Manufacturer Date | 2017-01-12 |
| Date Added to Maude | 2017-05-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHYSICAL THERAPIST |
| 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 | 4087765000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVAPATCH IONTOGO 4.0 |
| Generic Name | IONTOPHORESIS PATCH |
| Product Code | EGJ |
| Date Received | 2017-05-11 |
| Model Number | NC89189 |
| Catalog Number | NC89189 |
| Lot Number | BEW161002 |
| Device Expiration Date | 2018-12-28 |
| Operator | PHYSICAL THERAPIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Manufacturer Address | 8100 CAMINO ARROYO GILROY CA 95020 US 95020 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-11 |