MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-06 for CLEARGUARD HD ANTIMICROBIAL BARRIER CAP CGHD CGHD-100 manufactured by Pursuit Vascular, Inc..
| Report Number | 3011277191-2019-00003 |
| MDR Report Key | 8866810 |
| Report Source | USER FACILITY |
| Date Received | 2019-08-06 |
| Date of Report | 2019-07-31 |
| Date Mfgr Received | 2019-05-31 |
| Device Manufacturer Date | 2018-05-21 |
| Date Added to Maude | 2019-08-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAYSON BABLER |
| Manufacturer Street | 6901 EAST FISH LAKE ROAD SUITE 166 |
| Manufacturer City | MAPLE GROVE MN 553695456 |
| Manufacturer Country | US |
| Manufacturer Postal | 553695456 |
| Manufacturer Phone | 7633344284 |
| Manufacturer G1 | PURSUIT VASCULAR, INC. |
| Manufacturer Street | 6901 EAST FISH LAKE ROAD SUITE 166 |
| Manufacturer City | MAPLE GROVE MN 553695456 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 553695456 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARGUARD HD ANTIMICROBIAL BARRIER CAP |
| Generic Name | CLEARGUARD HD |
| Product Code | PEH |
| Date Received | 2019-08-06 |
| Model Number | CGHD |
| Catalog Number | CGHD-100 |
| Lot Number | 4918 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PURSUIT VASCULAR, INC. |
| Manufacturer Address | 6901 EAST FISH LAKE ROAD SUITE 166 MAPLE GROVE MN 553695456 US 553695456 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-06 |