MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2019-09-06 for 3D ACCUSCAN PATIENT SPECIFIC(R) IMPLANT N/A manufactured by Implantech Associates, Inc..
| Report Number | 2028924-2019-00005 |
| MDR Report Key | 8972035 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-09-06 |
| Date of Report | 2019-09-06 |
| Date of Event | 2019-07-02 |
| Date Mfgr Received | 2019-08-12 |
| Device Manufacturer Date | 2019-04-09 |
| Date Added to Maude | 2019-09-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3D ACCUSCAN PATIENT SPECIFIC(R) IMPLANT |
| Generic Name | CHEST WALL IMPLANT |
| Product Code | MIC |
| Date Received | 2019-09-06 |
| Model Number | N/A |
| Catalog Number | 3D ACCUSCAN |
| Lot Number | 882465 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | 6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-06 |