MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-10 for AFRI MEDICAL SYNFLO CS 540 ALL MODELS ALL CATAGLOGS manufactured by Afri Medical Co.
[438494]
Afri medical co. Which is cleared in the us market by establishment registration has been investigated by the local competent authority, and the investigation reveals a lot of breaching and violation which is followed by mandatory stop of the production line. The local competent authority has been contacted to confirm the action taken, and the injunction action has been confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038012 |
| MDR Report Key | 681554 |
| Date Received | 2006-02-10 |
| Date of Report | 2006-02-10 |
| Date of Event | 2005-10-01 |
| Date Added to Maude | 2006-03-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFRI MEDICAL SYNFLO CS 540 |
| Generic Name | SYNFLOW |
| Product Code | LLB |
| Date Received | 2006-02-10 |
| Model Number | ALL MODELS |
| Catalog Number | ALL CATAGLOGS |
| Lot Number | ALL LOTS |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 670821 |
| Manufacturer | AFRI MEDICAL CO |
| Manufacturer Address | INDUSTRIAL ZONE C3 10TH OF RAMADAN CITY EG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2006-02-10 |