FDA Adverse Event
Malfunction
Summary report: N
SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT
MDR report key: 1994017
·
Received February 16, 2011
Report
- Report Number
- 3005992282-2011-00046
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- January 1, 2006
- Report Date
- February 3, 2011
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD A GASTRIC BAND FITTED IN 2006/2007, THE BAND WORKED WELL FOR ONE YEAR AND THE PATIENT LOST A LOT OF WEIGHT. AFTER A YEAR, THE PATIENT COMPLAINED OF ABDOMINAL PAINS. UPON RETURN TO THE HOSPITAL, THEY DISCOVERED THAT THE PORT HAD BECOME DISCONNECTED FROM THE TUBING. THE SURGEON RECONNECTED A NEW PORT AND THE PATIENT HAS NOT EXPERIENCED ANY FURTHER PROBLEMS. THE CUSTOMER DISPOSED OF THE DEVICE.
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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |