FDA Adverse Event
Malfunction
Summary report: N
REALIZE ADJ GASTRIC BAND STR
MDR report key: 3140572
·
Received May 31, 2013
Report
- Report Number
- 3005992282-2013-00045
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Date of Event
- December 22, 2008
- Report Date
- July 20, 2012
- 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). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST IMPLANT A REALIZE BAND, CT SCAN FOR EXCRUCIATING PAIN TO MY RLQ SHOWED THE TUBING FROM THE REALIZE BAND WAS AT THE CECUM. THE BAND REMAINS IMPLANTED. SURGERY DATE NOT YET SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241157 | REALIZE ADJ GASTRIC BAND STR | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |