FDA Adverse Event
Death
Summary report: N
REALIZE ADJ GASTRIC BAND STR
MDR report key: 2547037
·
Received April 24, 2012
Report
- Report Number
- 3005992282-2012-00062
- Event Type
- Death
- Date Received
- April 24, 2012
- Date of Event
- August 8, 2008
- Report Date
- March 29, 2012
- Manufacturer
- OBTECH MEDICAL SARL_
- Product Code
- LTI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. THE LOT NUMBER WAS PROVIDED AND THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
OPERATIVE REPORT ATTACHED.
Description of Event or Problem · 1
EVENT REPORTED VIA NOTICE OF INTENT TO FILE LITIGATION. THE CLAIM ALLEGES THAT PATIENT WAS NOT PROPERLY MONITORED, ASSESSED AND INTERVENED TO PREVENT BOWEL OBSTRUCTION, GASTRIC PERFORATION, SEVERE SEPSIS, NECROSIS AND SEPTIC SHOCK. THIS RESULTED IN PATIENT HOSPITALIZATION FOR INTENSIVE CARE BEGINNING ON OR ABOUT (B)(6) 2010. PATIENT EXPIRED ON (B)(6) 2010. ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.
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 | ZJCBDN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |