D
Patient 1
PHYSICIAN REPORTED PORT FLIP IDENTIFIED BY ULTRASOUND IMAGING. DEVICE REMAINS IMPLANTED AND HAS NOT BEEN TREATED. FOLLOW UP FINDINGS: PHYSICIAN FLIPPED PORT 180 DEGREES AND SUTURED IT BACK IN PLACE. DEVICE REMAINS IMPLANTED.
MAUDE MDR 4723598
- MDR report key
- 4723598
- Report number
- 3006722112-2015-00027
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-02-23
- Date received
- 2015-04-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA LEBOEUF
- Address
- 1120 S CAPITAL OF TX 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 | 2015-04-21 | 0 |
Event Narratives#
N
Patient 1
(B)(4). RAPIDPORT EZ STRAIN RELIEF. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS IF IT IS EXPLANTED IN THE FUTURE. THE DEVICE WAS RESUTURED INTO PLACE AND REMAINS IMPLANTED. BASED UPON THE CATALOG NUMBER AND AN IMAGE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A RAPIDPORT EZ STRAIN RELIEF. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS, IF IT IS EXPLANTED IN THE FUTURE. IT WAS REPOSITIONED DURING THE PROCEDURE AND ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING SERIAL NUMBER, THE EVENT DATE, IMPLANT DATE, TREATMENT DATE, DIAGNOSTIC TESTING, PATIENT DATA OR FURTHER EVENT DETAILS.