MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS N/A 610133 manufactured by Terumo Medical Corporation.
| Report Number | 3013394970-2020-00167 |
| MDR Report Key | 9901476 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2019-10-23 |
| Date Added to Maude | 2020-03-30 |
| 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 | THERESA MUSSAW |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON, MD |
| Manufacturer Country | US |
| Manufacturer Phone | 2837866718 |
| Manufacturer G1 | TERUMO PUERTO RICO LLC |
| Manufacturer Street | INNOVACION STREET LOT 21 CAGUAS WEST INDUSTRIAL PARK |
| Manufacturer City | CAGUAS, 00725 |
| Manufacturer Postal Code | 00725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS |
| Generic Name | DEVICE, HEMOSTASIS, VASCULAR |
| Product Code | MGB |
| Date Received | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 610133 |
| Lot Number | 06099037 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO MEDICAL CORPORATION |
| Manufacturer Address | 265 DAVIDSON AVE SUITE 320 SOMERSET, NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |