MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-26 for PROVOX XTRAFLANGE 20 7226 manufactured by Atos Medical Ab.
| Report Number | 8032044-2019-00007 |
| MDR Report Key | 9375024 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-26 |
| Date of Report | 2019-10-28 |
| Date of Event | 2019-10-21 |
| Date Mfgr Received | 2019-10-28 |
| Date Added to Maude | 2019-11-26 |
| 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 | MRS KAROLINA NILSSON |
| Manufacturer Street | KRAFTGATAN 8, P:O: BOX 183 |
| Manufacturer City | H 24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | 24222 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8, P.O. BOX 183 |
| Manufacturer City | H 24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24222 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX XTRAFLANGE 20 |
| Generic Name | SILICONE WASHER INTENDED TO REDUCE PERIPROSTHETIC LEAKAGE |
| Product Code | EWL |
| Date Received | 2019-11-26 |
| Catalog Number | 7226 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | KRAFTGATAN 8, P.O. BOX 183 H?RBY, 24222 SW 24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-26 |