FDA Adverse Event
Malfunction
Summary report: N
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
MDR report key: 2122321
·
Received June 13, 2011
Report
- Report Number
- 3005992282-2011-00123
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- October 19, 2010
- Report Date
- May 10, 2011
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. (B)(4)
Description of Event or Problem · 1
SPOKE WITH THE (B)(6), OR MANAGER AND SHE ADVISE THAT THE ENTIRE BANDING SYSTEM WAS REMOVED. THE PATIENT DID NOT WANT THE BAND REPLACED AT THAT TIME, BUT SHE BELIEVES THE PATIENT CAME BACK AT A LATER DATE AND HAD A NEW BAND PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |