FDA Adverse Event
Malfunction
Summary report: N
REALIZE ADJ GASTRIC BAND-C
MDR report key: 1891276
·
Received November 4, 2010
Report
- Report Number
- 3005992282-2010-00346
- Event Type
- Malfunction
- Date Received
- November 4, 2010
- Date of Event
- October 11, 2010
- Report Date
- October 19, 2010
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED POST IMPLANT OF A LAPAROSCOPIC GASTRIC BAND DURING THE FIRST FILL, THE COULD NOT BE ACCESSED WITH THE HUBER NEEDLE. DIAGNOSTIC TEST REVEALED THE PORT HAD FLIPPED. THE STRAIN RELIEF WAS ON THE TUBING AND THE HOOKS WHEN OBSERVED WERE OPEN. THE PORT WAS REPLACED. THE SURGEON INSURED THE HOOKS WERE DEPLOYED USING THE PORT APPLIER AND COMPLETED THE FIRST FILL OF 4 CC OF FLUID DURING THE PROCEDURE. THE PATIENT IS HOME AND STABLE.
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 |