MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-22 for PASS LP B33225512-08 manufactured by Medicrea International.
| Report Number | 1000432246-2019-00014 |
| MDR Report Key | 9360443 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-22 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-10-08 |
| Date Mfgr Received | 2019-10-21 |
| Date Added to Maude | 2019-11-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARINE TROGNEUX |
| Manufacturer Street | 5389 ROUTE DE STRASBOURG |
| Manufacturer City | RILLIEUX-LA-PAPE, 69140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 69140 |
| Manufacturer G1 | MEDICREA INTERNATIONAL |
| Manufacturer Street | 5389 ROUTE DE STRASBOURG |
| Manufacturer City | RILLIEUX-LA-PAPE, 69140 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASS LP |
| Generic Name | UNID ROD |
| Product Code | MNI |
| Date Received | 2019-11-22 |
| Catalog Number | B33225512-08 |
| Lot Number | 0VJMQMXS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 0 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICREA INTERNATIONAL |
| Manufacturer Address | 5389 ROUTE DE STRASBOURG RILLIEUX-LA-PAPE, 69140 FR 69140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-22 |