MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-04-22 for DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..
[142688353]
Title: "greater omentum folding in the open surgical placement of peritoneal dialysis catheters: a randomized controlled study and systemic review. " source: nephrol dial transplant, volume 29, 2014 (687? 697). Date of publication: 30 september 2013. If information is provided in the future, a supplemental report will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142688354]
According to literature source of study performed between march 2008 to december 2012, to analyze the outcomes of omentum management in pd catheter implantation,a total of 67 pd subjects were enrolled in the study and randomly assigned to receive either regular open insertion (roi group, n = 33) or open insertion with omentum folding (oiof group, n = 34). The primary outcome was defined as pd catheter tip migration with dysfunction. In both groups, all patients received a straight two-cuff pd catheter. In the course of this study, catheter-associated infections occurred with similar frequency in the roi (n = 8; 24. 2%) and oiof group (n = 9; 26. 5%; p = 0. 980), including peritonitis (6. 1 versus 8. 8%; p = 0. 724), tunnel infections (0 versus 2. 9%, p = 0. 621) and exit-site infections (18. 2 versus 14. 7%, p =0. 623).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00096 |
| MDR Report Key | 8537793 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2019-04-22 |
| 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 | DIALYSIS UNKNOWN |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | FJS |
| Date Received | 2019-04-22 |
| Model Number | DIALYSIS UNKNOWN |
| Catalog Number | DIALYSIS UNKNOWN |
| 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 | 2019-04-22 |