MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-04-24 for UNKNOWN PERITONEAL CATHETER manufactured by Covidien Mfg Solutions S.a..
[142910180]
Title: peritoneal dialysis catheter placement, outcomes and complications source pediatric surgery international, volume 34, 2018 (1239? 1244). Date of publication: 4 september 2018. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142910181]
According to literature source of study performed at two institutions, 14% of patients developed leakage, 10% of patients developed infection, 6% of patients had adhesions requiring surgery, 6% of patients had catheter migration and 10% of patients had associated ventral hernias out of the 157 catheters placed ranging in age from 1 day to 23 years. Of the catheters that required replacement, 36% of patients had leakage, 14% of patients had catheter migration, 5% of patients had adhesion, 18% of patients were infected, and 5% of patients had a hernia. The catheters used were curl-type peritoneal dialysis catheters or catheters of a very similar type. The patients that underwent an omentectomy were 75% less likely to require a catheter replacement. It was found out that laparoscopic intervention resulted in catheter salvage, lateral exit sites may be a risk factor for catheter migration in some patients, and omentectomy is associated with longer pd (peritoneal dialysis) catheter survival. Laparoscopic salvage of dysfunctional catheters may be a valuable adjunct in management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00103 |
| MDR Report Key | 8544589 |
| Report Source | LITERATURE |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-04-24 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| 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 CATHETER |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | FJS |
| Date Received | 2019-04-24 |
| Model Number | UNKNOWN PERITONEAL CATHETER |
| Catalog Number | UNKNOWN PERITONEAL CATHETER |
| 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. Other | 2019-04-24 |