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 2019-11-15 for CATH PKGD: WEDGE 6 FR 110 CM AI-07126 manufactured by Arrow International Inc..
| Report Number | 3010532612-2019-00405 |
| MDR Report Key | 9330279 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-15 |
| Date of Report | 2019-10-24 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-10-24 |
| Device Manufacturer Date | 2019-02-20 |
| Date Added to Maude | 2019-11-15 |
| 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 | CARMEN SHERMAN |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9782505100 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATH PKGD: WEDGE 6 FR 110 CM |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2019-11-15 |
| Catalog Number | AI-07126 |
| Lot Number | 16F19B0087 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-15 |