FDA Adverse Event
Summary report: N
PERFADEX PLUS
MDR report key: 12894285
·
Received November 29, 2021
Report
- Report Number
- MW5105672
- Date Received
- November 29, 2021
- Report Date
- July 6, 2021
- Manufacturer
- XVIVO PERFUSION AB
- Product Code
- KDN
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THERE SEEMS TO BE A DISCREPANCY WITH THE EXPIRATION DATE OF THE PERFADEX AND LOT# 201117641S. THE OUTER CONTAINER AND STICKER ON PRODUCT BAG SHOWS AN EXPIRATION DATE OF 20210831 AND "8/21," RESPECTIVELY, BUT THE STAMPED EXPIRATION DATE ON THE OTHER SIDE OF THE PRODUCT SHOWS "2/21." WE ARE SEQUESTERING PRODUCT AND NOT USING GIVEN THIS DISCREPANCY. WHEN WE CALLED THE COMPANY TO REPORT, (B)(4), WE COULD NOT GET THROUGH. WE DID EMAIL THEM THIS INFORMATION - [email protected] (MAILTO:[email protected]). TECHNICALLY I THINK THIS SOLUTION IS A MEDICAL DEVICE, BUT FELT THAT THIS MAY STILL BE RELEVANT TO (B)(6). MFR/LABELER INACCURATE INFO (LABEL/LABELING). THANK YOU. (B)(6). SUBMISSION ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1786170 | PERFADEX PLUS | SYSTEM, PERFUSION, KIDNEY | KDN | XVIVO PERFUSION AB | 19850 | 201117641S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |