N
Patient 1
DEVICE DISCARDED BY PATIENT.
MAUDE MDR 6562011
- MDR report key
- 6562011
- Report number
- 2939821-2017-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-03-31
- Date received
- 2017-05-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 111
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. JENNIFER MOFFATT
- Address
- 8100 CAMINO ARROYO GILROY CA 95020 US
- Phone
- 408-408-4087
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACTIVAPATCH IONTOGO 4.0 | IONTOPHORESIS PATCH | NORTH COAST MEDICAL, INC. | EGJ | NC89189 | NC89189 | BEW161002 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-11 | 0 | 1. R |
Event Narratives#
D
Patient 1
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."