FDA Adverse Event
Malfunction
Summary report: N
REALIZE ADJ GASTRIC BAND-C
MDR report key: 1902719
·
Received November 18, 2010
Report
- Report Number
- 3005992282-2010-00366
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- October 28, 2010
- Report Date
- October 28, 2010
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- 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 THAT POST-IMPLANT OF THE LAPAROSCOPIC ADJUSTABLE BAND, THE TUBING BECAME COMPLETELY DISCONNECTED. THE METAL COMPONENT WAS ON THE PORT. THE LOCATION OF THE STRAIN RELIEF IS UNKNOWN. ON (B)(6), 2010 THE PORT WAS REPLACED WITH NO PATIENT CONSEQUENCE. THE PORT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REALIZE ADJ GASTRIC BAND-C | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |