N
Patient 1
(B)(4) THE DEVICE INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO THE MANUFACTURER. HOWEVER, THE INVESTIGATION INTO SAID DEVICE IS STILL IN PROGRESS AT THE TIME OF THIS REPORT.
MAUDE MDR 6253794
- MDR report key
- 6253794
- Report number
- 1722554-2017-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-20
- Date received
- 2017-01-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KATHARINE TARPLEY
- Address
- 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
- Phone
- 919-919-9194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MAD NASAL WITHOUT SYRINGE | MUCOSAL ATOMIZATION DEVICE | WOLFE TORY MEDICAL INC. | CCQ | MAD300 | 160518 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-16 | 0 |
Event Narratives#
D
Patient 1
CUSTOMER COMPLAINT ALLEGES THAT "THE MAD300 PACKAGING WAS MISSING THE VARIABLE LOT PRINTING". ALLEGED ISSUE WAS DETECTED DURING INCOMING INSPECTION, PRIOR TO PATIENT INVOLVEMENT.
N
Patient 1
(B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE CUSTOMER RETURNED A PHOTO. THE PHOTO CONFIRMED THAT THE POUCH HAS INCOMPLETE PRINTING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. THE PRODUCT WAS PLACED ON SHIP HOLD AND A CAPA WAS OPENED TO ADDRESS THIS ISSUE.
D
Patient 1
CUSTOMER COMPLAINT ALLEGES THAT "THE MAD300 PACKAGING WAS MISSING THE VARIABLE LOT PRINTING". ALLEGED ISSUE WAS DETECTED DURING INCOMING INSPECTION, PRIOR TO PATIENT INVOLVEMENT.