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 2020-02-18 for AQUA-SEAL CDU 8888571299 manufactured by Covidien.
[188507993]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.? As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.? If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10
[188507994]
The customer reported that the trap does not release pressure and acts as a one-way valve to the pleural cavity. The patient presented pneumothorax when using the system. It is unknown what medical intervention was given to the patient. The current status of the patient is also unknown. No other information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611018-2020-00404 |
| MDR Report Key | 9721994 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-18 |
| 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 | 2020-02-18 |
| Model Number | 8888571299 |
| Catalog Number | 8888571299 |
| Lot Number | 19D260FHX |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Other | 2020-02-18 |