MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-01-22 for PAK NEEDLE TROCAR/TROCAR PK1002 manufactured by Lacey Manufacturing Company Llc.
| Report Number | 1218017-2019-00005 |
| MDR Report Key | 9618390 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-01-22 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2019-08-01 |
| Date Added to Maude | 2020-01-22 |
| 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 ROGERS |
| Manufacturer Street | 1146 BARNUM AVENUE |
| Manufacturer City | BRIDGEPORT CT 06610 |
| Manufacturer Country | US |
| Manufacturer Postal | 06610 |
| Manufacturer Phone | 2033367453 |
| Manufacturer G1 | LACEY MANUFACTURING COMPANY LLC |
| Manufacturer Street | 1146 BARNUM AVENUE |
| Manufacturer City | BRIDGEPORT CT 06610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06610 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAK NEEDLE TROCAR/TROCAR |
| Generic Name | PEDICLE ACCESS NEEDLE |
| Product Code | PDQ |
| Date Received | 2020-01-22 |
| Model Number | PK1002 |
| Catalog Number | PK1002 |
| Lot Number | BE3967 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LACEY MANUFACTURING COMPANY LLC |
| Manufacturer Address | 1146 BARNUM AVENUE BRIDGEPORT CT 06610 US 06610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-22 |