FDA Adverse Event
Death
Summary report: N
PROCEED MULTI-LAYER LAMINATE MESH
MDR report key: 1211471
·
Received October 24, 2008
Report
- Report Number
- 2210968-2008-01040
- Event Type
- Death
- Date Received
- October 24, 2008
- Date of Event
- September 21, 2008
- Report Date
- September 25, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K060713
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT AN UNEVENTFUL HIATAL HERNIA REPAIR WITH MESH IMPLANT. THE PATIENT DEVELOPED CLINICAL SYMPTOMS CONSISTENT WITH BACTERIAL SEPSIS THREE DAYS POST PROCEDURE. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT EXPIRED THE FOLLOWING DAY, DUE TO A MULTIPLE ORGAN FAILURE DUE TO GENERALIZED SEPSIS. NO AUTOPSY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROCEED MULTI-LAYER LAMINATE MESH | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC. | NA | ADG217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Death |