FDA Adverse Event
Injury
Summary report: N
REALIZE ADJ GASTRIC BAND STR
MDR report key: 2073142
·
Received April 29, 2011
Report
- Report Number
- 3005992282-2011-00104
- Event Type
- Injury
- Date Received
- April 29, 2011
- Date of Event
- June 1, 2010
- Report Date
- April 6, 2011
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
CONSUMER REPORTS THAT, "I NO LONGER HAVE THE REALIZE BAND AS IT WAS REMOVED BY EMERGENCY SURGERY IN (B)(6) 2010. IT SLIPPED AND STRANGLED MY STOMACH." ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REALIZE ADJ GASTRIC BAND STR | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |