FDA Adverse Event
Malfunction
Summary report: N
REALIZE ADJ GASTRIC BAND-C
MDR report key: 2990397
·
Received March 5, 2013
Report
- Report Number
- 3005992282-2013-00024
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Report Date
- February 7, 2013
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION UNAVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST OP, A REALIZE BAND PLACEMENT THE PATIENT RETURNED TO THE SURGEON FOR A FILL. DURING THE VISIT, THE SURGEON DECIDED THAT THE INJECTION PORT WAS NOT WORKING PROPERLY AND DECIDED TO REPLACE THE PORT. THE PORT WAS DISCARDED. ADDITIONAL FOLLOW UP WAS CONDUCTED. FOR SPECIFIC DETAILS ON WHAT IS MEANT PORT NOT WORKING PROPERLY. IF ADDITIONAL DETAILS BECOME AVAILABLE, A 3500 A SUPPLEMENTAL WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93443 | REALIZE ADJ GASTRIC BAND-C | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |