MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-04-30 for PERITONEAL CATHETER manufactured by Covidien Mfg Solutions S.a..
[143616108]
Title: "comparison between the fixation of peritoneal dialysis catheters to the peritoneal wall and the conventional placement technique: clinical experience and follow-up of a new implant technique for peritoneal dialysis catheters. " source: seminars in dialysis, volume 27, 2014 (e42? E47). Article number: 4. Date of publication: 2014, july-august. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143616109]
According to literature source of study performed, peritoneal dialysis catheters were implanted in 41 patients wherein peritoneal dialysis treatments were performed for more than three months and had been subject to capd (continuous ambulatory peritoneal dialysis). In the first 2 years, 16 patients were implanted using the conventional placement technique. In the 3 years from 2006, 25 patients were implanted using a method of fixing the catheter downward in the peritoneal cavity (fixation technique). Mechanical complications as those that were not infectious complications related to the catheter (including peritonitis, exit-site infection, and tunnel infection), and those that were neither medical nor psychosocial. Infectious complications related to pd catheter were exit-site infection, tunnel infection, and peritonitis. Mechanical complications related to the insertion procedure, the presence of dialysate in the peritoneum, problems secondary to abdominal events, catheter accidents, and cuff extrusion did not occur with either the fixation or conventional technique. Infectious complications were not significantly different among the fixation or conventional technique for exit-site infections, tunnel infections, and peritonitis. Mechanical complications due to catheter obstruction occurred in one case in the fixation technique group and in two cases in the conventional group.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00107 |
| MDR Report Key | 8566761 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-04-30 |
| 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 ST. |
| 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 | PERITONEAL CATHETER |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | FJS |
| Date Received | 2019-04-30 |
| Model Number | PERITONEAL CATHETER |
| Catalog Number | 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. Required No Informationntervention | 2019-04-30 |