FDA Adverse Event
Injury
Summary report: N
SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT
MDR report key: 2123532
·
Received June 14, 2011
Report
- Report Number
- 3005992282-2011-00136
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- December 17, 2010
- Report Date
- May 24, 2011
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
PATIENT 16 ENROLLED IN THE (B)(6) REGISTRY HAD AN ESOPHAGEAL DILATATION SEEN BY RADIOLOGIC EXAM AT THREE YEAR FOLLOW UP VISIT. THE BAND WAS DEFLATED -4CC FOR A FINAL TOTAL AT 1CC. THERE WERE NO OTHER REPORTED PATIENT COMPLICATIONS. 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 | SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK | 20005244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |