FDA Adverse Event
Malfunction
Summary report: N
REALIZE ADJ GASTRIC BAND-C
MDR report key: 2002659
·
Received February 28, 2011
Report
- Report Number
- 3005992282-2011-00058
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- August 25, 2010
- Report Date
- February 25, 2011
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADJUSTABLE BAND PROCEDURE, THE DEVICES TUBING GOT CAUGHT UNDER THE PORT AND NICKED. THE SURGEON SHORTENED THE TUBING AND ATTACHED IT TO THE PORT. LATER ON AN UNKNOWN DATE, THE SURGEON DETERMINED THAT THE TUBING HAD DISCONNECTED FROM THE PORT USING FLUOROSCOPY. A COMPETITOR'S BAND AND PORT WILL BE IMPLANTED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REALIZE ADJ GASTRIC BAND-C | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |