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 2019-12-13 for PRESSURE MONITORING KIT TC0209SA01 manufactured by Edwards Lifesciences Dr.
[188703920]
The device evaluation is anticipated. However, the complaint cannot not be confirmed without the completion of a product evaluation. A supplemental report will be forthcoming with the evaluation and device history results when received.
Patient Sequence No: 1, Text Type: N, H10
[188703921]
It was reported that an unknown white material was found attached to the inner surface of the iv tubing of this disposable pressure transducer before use. Patient demographic information was requested but unavailable. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-04650 |
| MDR Report Key | 9467912 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-13 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2019-12-13 |
| 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 | MRS SAMANTHA EVELEIGH |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES DR |
| Manufacturer Street | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSURE MONITORING KIT |
| Generic Name | TRANSDUCER, PRESSURE, CATHETER TIP |
| Product Code | DXO |
| Date Received | 2019-12-13 |
| Returned To Mfg | 2019-12-12 |
| Model Number | TC0209SA01 |
| Lot Number | LJ0296MT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES DR |
| Manufacturer Address | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-13 |