MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-25 for MAHURKAR 8888101002 manufactured by Kendall Company Argyle Plant.
| Report Number | 1317749-2019-00001 |
| MDR Report Key | 8731689 |
| Date Received | 2019-06-25 |
| Date of Report | 2019-06-25 |
| Date Mfgr Received | 2009-12-09 |
| Date Added to Maude | 2019-06-25 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | KENDALL COMPANY ARGYLE PLANT |
| Manufacturer Street | 5439 STATE ROUTE 40 |
| Manufacturer City | ARGYLE NY 128093830 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 128093830 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAHURKAR |
| Generic Name | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | NIE |
| Date Received | 2019-06-25 |
| Returned To Mfg | 2010-01-12 |
| Model Number | 8888101002 |
| Catalog Number | 8888101002 |
| Lot Number | 913691 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KENDALL COMPANY ARGYLE PLANT |
| Manufacturer Address | 5439 STATE ROUTE 40 ARGYLE NY 128093830 US 128093830 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-25 |