TBD
Report
- Report Number
- 1718850-2020-01144
- Event Type
- Injury
- Date Received
- September 20, 2020
- Date of Event
- May 20, 2020
- Report Date
- October 23, 2020
- Manufacturer
- SORIN GROUP ITALIA S.R.L.
- Product Code
- KRH
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
TYPO IN PREVIOUS IMPORTER REPORT IN SECTION B5. THE INFORMATION WAS RECEIVED ON SEP 25, 2020 NOT SEP. 22, 2020. THE NEW ADDITIONAL INFORMATION IN SECTION B5 IS AS FOLLOWS: ADDITIONAL INFORMATION RECEIVE ON SEP 25, 2020 IDENTIFYING THAT BOTH VALVES WERE IMPLANTED IN TWO DIFFERENT LOCATIONS. AS SUCH THERE IS NO ADVERSE EVENT.
ADDITIONAL INFORMATION RECEIVE ON SEP 22, 2020 IDENTIFYING THAT BOTH VALVES WERE IMPLANTED IN TWO DIFFERENT LOCATIONS. AS SUCH THERE IS NO ADVERSE EVENT. THE CASE WILL BE CLOSED WITH NO FURTHER INVESTIGATION AS NO ADVERSE EVENT OCCURRED.
ADDITIONAL INFORMATION RECEIVE ON SEP 25, 2020 IDENTIFYING THAT BOTH VALVES WERE IMPLANTED IN TWO DIFFERENT LOCATIONS. AS SUCH THERE IS NO ADVERSE EVENT.
ADDITIONAL INFORMATION RECEIVE ON SEP 22, 2020 IDENTIFYING THAT BOTH VALVES WERE IMPLANTED IN TWO DIFFERENT LOCATIONS. AS SUCH THERE IS NO ADVERSE EVENT.
THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING EVENT VIA THE PATIENT TRACKING DATABASE. ON (B)(6) 2020 A PATIENT HAD 2 MITRAL VALVES IMPLANTED ON THE SAME DAY BUT IT IS NOT IDENTIFIED WHICH ONE IS ACTIVE AND WHICH ONE WAS EXPLANTED. A MEMO 4DM-34 AND A ANNULOFLEX AF-834. NO FURTHER INFORMATION WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1022769 | TBD | TBD | KRH | SORIN GROUP ITALIA S.R.L. | TDB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |