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 2019-08-20 for AQUA-SEAL CDU 8888571299 manufactured by Covidien.
| Report Number | 9611018-2019-00315 |
| MDR Report Key | 8913350 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-20 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-08-09 |
| Date Mfgr Received | 2019-08-09 |
| Date Added to Maude | 2019-08-20 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | SRAGH INDUSTRIAL ESTATE, CO, T |
| Manufacturer City | OFFALY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUA-SEAL CDU |
| Generic Name | BOTTLE, COLLECTION, VACUUM |
| Product Code | KDQ |
| Date Received | 2019-08-20 |
| Model Number | 8888571299 |
| Catalog Number | 8888571299 |
| Lot Number | 18F133FHX |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | SRAGH INDUSTRIAL ESTATE, CO, T OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-20 |