FDA Adverse Event
Malfunction
Summary report: N
SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT
MDR report key: 1071869
·
Received July 9, 2008
Report
- Report Number
- 3005992282-2008-00098
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- November 26, 2007
- Report Date
- June 27, 2008
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP ADJUSTABLE BAND PROCEDURE, A KNOT WAS TIED IN THE CATHETER. THE BAND HAD RE-INFLATED. A TEAR WAS NOTED ON THE BAND. THERE WAS NO PT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT | LTI | OBTECH MEDICAL SARL | NA | ZHGBDK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |