MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for PHYSIQUE SCREWVINE 52 SEP manufactured by .
| Report Number | 1000165971-2019-00395 |
| MDR Report Key | 8752767 |
| Date Received | 2019-07-02 |
| Date of Report | 2019-09-02 |
| Date of Event | 2019-03-27 |
| Date Facility Aware | 2019-06-13 |
| Date Mfgr Received | 2019-08-23 |
| Date Added to Maude | 2019-07-02 |
| 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 | ELODIE VINCENT |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| Manufacturer Phone | 0146013665 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PHYSIQUE |
| Generic Name | PERMANENT PACING LEAD |
| Product Code | DTB |
| Date Received | 2019-07-02 |
| Model Number | SCREWVINE 52 SEP |
| Catalog Number | SCREWVINE 52 SEP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer Address | CLAMART 92140 FR 92140 |
| Brand Name | PHYSIQUE |
| Generic Name | PERMANENT PACING LEAD |
| Product Code | OSR |
| Date Received | 2019-07-02 |
| Model Number | SCREWVINE 52 SEP |
| Catalog Number | SCREWVINE 52 SEP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | CLAMART 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-02 |