D
Patient 1
HEALTHCARE PROFESSIONAL REPORTS A POSSIBLE ALLERGIC REACTION, PATIENT IS "EXPERIENCING PAINFUL RED RAISED RASHES OVER HER BODY."
MAUDE MDR 4788067
- MDR report key
- 4788067
- Report number
- 3006722112-2015-00043
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-04-21
- Date received
- 2015-05-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA LEBOUEF
- Address
- 1120 S CAPITAL OF TEXAS HWY BLDG 1, STE 300 AUSTIN TX 78746 US
- Phone
- 855-855-8555
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-05-19 | 0 |
Event Narratives#
N
Patient 1
TAPER UNKNOWN. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED, NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT, BECAUSE NO SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE.
N
Patient 1