FDA Adverse Event
Malfunction
Summary report: N
REALIZE ADJ GASTRIC BAND-C
MDR report key: 2090260
·
Received May 16, 2011
Report
- Report Number
- 3005992282-2011-00115
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- March 30, 2011
- Report Date
- May 6, 2011
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC REALIZE ADJUSTABLE BAND PROCEDURE, A LEAK WAS DETECTED IN THE BALLOON OF THE BAND. A NEW BAND WAS PULLED AND IMPLANTED. THERE WAS NO PATIENT IMPACT. THE BAND WAS DISCARDED.
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 |