MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for PERMCATH 8815132001 manufactured by Covidien Mfg Solutions S.a..
| Report Number | 3009211636-2019-00226 |
| MDR Report Key | 9180706 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-11-07 |
| Date of Event | 2019-09-12 |
| Date Mfgr Received | 2019-10-24 |
| Device Manufacturer Date | 2016-04-15 |
| Date Added to Maude | 2019-10-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMCATH |
| Generic Name | CANNULA, A-V SHUNT |
| Product Code | FIQ |
| Date Received | 2019-10-11 |
| Model Number | 8815132001 |
| Catalog Number | 8815132001 |
| Lot Number | 1610400168 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-11 |