FDA Adverse Event
Injury
Summary report: N
REALIZE ADJ GASTRIC BAND STR
MDR report key: 1811627
·
Received August 23, 2010
Report
- Report Number
- 3005992282-2010-00245
- Event Type
- Injury
- Date Received
- August 23, 2010
- Date of Event
- August 19, 2010
- Report Date
- August 19, 2010
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT.INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED BY THE SURGEON THAT APPROXIMATELY TWO YEARS POST IMPLANT A REALIZE BAND, THE PATIENT PRESENTED WITH A PORT SITE INFECTION. THE PATIENT WAS SCOPED AND IT WAS DETERMINED THAT THE BAND HAD ERODED INTO THE LUMEN OF THE STOMACH. A CULTURE WAS NOT TAKEN. THE BAND WAS EXPLANTED WITHOUT ANY FURTHER COMPLICATIONS THE PATIENT.
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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |