MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-10-18 for UNKNOWN PERITONEAL DIALYSIS CATHETER UNK DY manufactured by Covidien Mfg Solutions S.a..
[89631873]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[89631874]
The customer reports on the (b)(6) 2017 the patient incurred peritonitis as a result of a rupture of the peritoneal dialysis catheter. The pd tube was damaged near the stomach. The patient had stopped peritoneal dialysis treatment. The patient sought intervention and purchased medicine to manage the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-05324 |
| MDR Report Key | 6959032 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-10-18 |
| Date of Report | 2017-10-18 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-12 |
| Date Added to Maude | 2017-10-18 |
| 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 | DIANE MATHEUS |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084521480 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN PERITONEAL DIALYSIS CATHETER |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2017-10-18 |
| Model Number | UNK DY |
| Catalog Number | UNK DY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-18 |