FDA Adverse Event
Injury
Summary report: N
REALIZE ADJ GASTRIC BAND STR
MDR report key: 2003294
·
Received February 28, 2011
Report
- Report Number
- 3005992282-2011-00061
- Event Type
- Injury
- Date Received
- February 28, 2011
- Date of Event
- November 14, 2010
- Report Date
- February 10, 2011
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED TWO DAYS POST OP A REALIZE ADJUSTABLE BAND IMPLANT, THE BAND WAS REMOVED DUE TO INFECTION. THE PATIENT PRESENTED WITH ELEVATED TEMPERATURE. IT IS UNKNOWN IF A CULTURE WAS PERFORMED. THE BAND AND PORT WERE REMOVED AND DISCARDED. THE PATIENT WAS GIVEN ANTIBIOTICS AND HAS MADE A FULL RECOVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REALIZE ADJ GASTRIC BAND STR | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | LTI | OBTECH MEDICAL SARL_ | UNK | ZLLBCR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |