MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for ACCUSHAPE MC-SPK30 manufactured by Medcad.
| Report Number | 3009196021-2020-00005 |
| MDR Report Key | 9904291 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-06-28 |
| Date Added to Maude | 2020-03-31 |
| 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 | MR. JAMES ALLO |
| Manufacturer Street | 501 SOUTH SECOND AVE SUITE A1000 |
| Manufacturer City | DALLAS, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 4538864 |
| Manufacturer G1 | MEDCAD |
| Manufacturer Street | 501 SOUTH SECOND AVE SUITE A1000 |
| Manufacturer City | DALLAS, TX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUSHAPE |
| Generic Name | CRANIPLASTY PLATE |
| Product Code | GXN |
| Date Received | 2020-03-31 |
| Model Number | MC-SPK30 |
| Catalog Number | MC-SPK30 |
| Lot Number | 193764BAK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDCAD |
| Manufacturer Address | 501 SOUTH SECOND AVE SUITE A1000 DALLAS, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |