FDA Adverse Event
Injury
Summary report: N
REALIZE ADJ GASTRIC BAND STR
MDR report key: 1480020
·
Received September 21, 2009
Report
- Report Number
- 3005992282-2009-00274
- Event Type
- Injury
- Date Received
- September 21, 2009
- Date of Event
- May 20, 2009
- Report Date
- August 27, 2009
- Manufacturer
- OBTECH MEDICAL SARL
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 9/21/2009. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST-OP A LAP ADJUSTABLE BAND PROCEDURE, THE PORT SITE WOULD NOT HEAL, SO THE PORT WAS REMOVED IN 2009, AND THEY ARE WAITING TO SEE IF THE SITE HEALS PRIOR TO RE-OPERATING TO REPLACE IT. FOUR ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REALIZE ADJ GASTRIC BAND STR | LTI | OBTECH MEDICAL SARL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |