FDA Adverse Event
Death
Summary report: N
PARIETEX STD 3D PY 20 X 20 CM X1
MDR report key: 2978568
·
Received February 21, 2013
Report
- Report Number
- 9615742-2013-00123
- Event Type
- Death
- Date Received
- February 21, 2013
- Date of Event
- November 13, 2012
- Report Date
- January 25, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTP
- PMA / PMN Number
- K982532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: UNK. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT A MAN AGED (B)(6) WAS OPERATED FOR INFECTION ((B)(6)). THE PT HAD BEEN SUFFERING FROM A CHRONIC PURULENT DISCHARGE FOR MONTHS. THE DEVICE WAS REMOVED ON (B)(6) (THE PARIETEX HAD BEEN APPLIED ON (B)(6) 2012). TWO DAYS LATER, ON (B)(6), THE PT DIED OF SCEPTIC SHOCK. THE DEVICE WAS UNFORTUNATELY THROWN AWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76751 | PARIETEX STD 3D PY 20 X 20 CM X1 | IMPLANTABLE MESH | OTP | SOFRADIM PRODUCTION | SLF00172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death |