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 2018-09-25 for AQUA-SEAL CDU 8888571299 manufactured by Covidien.
[121581231]
The customer states the aquaseal was not sucking adequately during drainage of a hemothorax so the surgeon indicated to change to a different product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611018-2018-00301 |
| MDR Report Key | 7905320 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-25 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-09-03 |
| Date Added to Maude | 2018-09-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| 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 | CHEST DRAINAGE KIT |
| Product Code | PAD |
| Date Received | 2018-09-25 |
| Model Number | 8888571299 |
| Catalog Number | 8888571299 |
| Lot Number | 17E041FHX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-09-25 |