FDA Adverse Event
Malfunction
Summary report: N
GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
MDR report key: 3120412
·
Received May 20, 2013
Report
- Report Number
- 3005992282-2013-00043
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Date of Event
- May 10, 2013
- Report Date
- May 10, 2013
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. DEVICE LOCATION UNKNOWN.
Description of Event or Problem · 1
THE PATIENT HAD A BAND ADJUSTMENTS AND NO LEAKS PREVIOUSLY DETECTED. A SUSPECTED LEAK WAS DUE TO SURGEON'S INABILITY TO ADJUST THE BAND. THE BAND WAS REPLACED AND EVERYTHING IS FINE NOW. THE BAND WAS DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT SEVEN MONTHS POST IMPLANT AN ADJUSTABLE BAND, AS A LEAK WAS FOUND FROM THE TUBE CONNECTING SITE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222540 | GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |