FDA Adverse Event
Injury
Summary report: N
REALIZE ADJ GASTRIC BAND-C
MDR report key: 3170688
·
Received June 14, 2013
Report
- Report Number
- 3005992282-2013-00047
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- June 11, 2012
- Report Date
- May 21, 2013
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT POST IMPLANT THE REALIZE BAND THAT AFTER (B)(6) 2013, SHE BEGAN HAVING PROBLEMS EATING, VOMITING, CHEST PAIN AND NAUSEA. SHE HAS BEEN SEEN BY A GI PHYSICIAN, WHO HAS RECOMMENDED REMOVAL OF THE BAND. THE PATIENT STATES SHE IS SOMETIMES UNABLE TO EVEN FINISH HER MEAL WITHOUT VOMITING. ADDITIONAL ATTEMPTS HAVE BEEN MADE TO PATIENT BUT HAS NOT MADE CONTACT. A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270928 | REALIZE ADJ GASTRIC BAND-C | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |