MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-29 for ACCUTIP CP-AT2235Q manufactured by Dr. Japan Co. Ltd..
| Report Number | 1058382-2019-00006 |
| MDR Report Key | 9252431 |
| Date Received | 2019-10-29 |
| Date of Report | 2019-10-29 |
| Date of Event | 2019-10-03 |
| Date Facility Aware | 2019-10-04 |
| Report Date | 2019-10-29 |
| Date Reported to FDA | 2019-10-29 |
| Date Reported to Mfgr | 2019-10-07 |
| Date Added to Maude | 2019-10-29 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUTIP |
| Generic Name | ANESTHESIA NEEDLE |
| Product Code | BSP |
| Date Received | 2019-10-29 |
| Catalog Number | CP-AT2235Q |
| Lot Number | LN-81207L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR. JAPAN CO. LTD. |
| Manufacturer Address | 1-1 KAGURAZAKA, SHINJUKU-KU TOKYO, 162-0825 JA 162-0825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-29 |