D
Patient 1
PHYSICIAN REPORTED THAT PATIENT HAD ABDOMINAL PAIN SINCE DEVICE WAS IMPLANTED FOUR WEEKS AGO. PORT ANCHOR WAS TWISTED SIDEWAYS. PORT WAS EXPLANTED AND REPLACED.
MAUDE MDR 4729618
- MDR report key
- 4729618
- Report number
- 3006722112-2015-00009
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-02-27
- Date received
- 2015-04-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. LAURA LEBOEUF
- Address
- 1120 S CAPITAL OF TEXAS HWY BULDING 1, SUITE 300 AUSTIN TX 78748 US
- Phone
- 855-855-8555
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AP SM W/RAPIDPORT EZ_NEXT GEN | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | ALLERGAN (COSTA RICA) | LTI | NA | C-20360 | 2655563 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-04-23 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
(B)(4). THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE 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. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. ABDOMINAL PAIN IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.
N
Patient 1
RAPIDPORT EZ STRAIN RELIEF. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A RAPIDPORT EZ STRAIN RELIEF. ANALYSIS NOTED THAT TWO ANCHORS WERE OUTSIDE THE ACCESS PORT. ANALYSIS NOTED A STRIATED OPENING IN THE BAND TUBING CONSISTENT WITH SURGICAL REMOVAL OF THE DEVICE. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF DEVICE APPEARANCE WITH RESPECT TO PORT ANCHORS AS FOLLOWS: ?CAUTION: THE ACCESS PORT MUST BE SECURELY FASTENED TO THE PATIENT?S RECTUS FASCIA WITH ALL FOUR OF THE STAINLESS STEEL ANCHORS FIRMLY EMBEDDED IN THE PATIENT?S FASCIA. IF THIS IS NOT ACHIEVED, THE ACCESS PORT MAY BECOME LOOSE AND INACCESSIBLE FOR POST-OPERATIVE ADJUSTMENTS, THUS REQUIRING REVISIONAL SURGERY.?
D
Patient 1
PHYSICIAN REPORTED THAT PATIENT HAD ABDOMINAL PAIN SINCE DEVICE WAS IMPLANTED FOUR WEEKS AGO. PORT ANCHOR WAS TWISTED SIDEWAYS. PORT WAS EXPLANTED AND REPLACED.