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 2017-01-27 for UNKNOWN DY manufactured by Covidien.
[65998359]
Submit date: 1/27/2017. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[65998360]
It was reported to covidien on (b)(6) 2017 that a customer experienced an adverse event with a dialysis catheter. The customer states that in (b)(6)2016, the tube was broken near the stomach. It led to peritonitis and the doctor replaced the tube and used cefradine treatment. Peritoneal dialysis was continued during treatment. The tube was cut.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-00061 |
| MDR Report Key | 6283871 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-09 |
| Date Mfgr Received | 2017-01-09 |
| Date Added to Maude | 2017-01-27 |
| 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 | 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 | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DY |
| Generic Name | DIALYSIS CATHETER |
| Product Code | FKO |
| Date Received | 2017-01-27 |
| Model Number | UNKNOWN DY |
| Catalog Number | UNKNOWN DY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-27 |