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..
[142725011]
Title preliminary report: cystoscopy-assisted peritoneal dialysis catheter placement? A direct, visual, safe, precise, easy, minimally invasive, and inexpensive technique source clinical nephrology, volume 81, 2014 (247-250) article number: 4 date of publication: 12 march 2014. If information is provided in the future, a supplemental report will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142725012]
According to literature source of study performed between march 2009 to november 2012. 29 patients with esrd underwent pd catheter placement, 14 patients underwent cystoscopy-assisted surgery (group a) and the remaining 15 patients underwent conventional open surgery (group b) for placement of the standard double-cuff swan-neck pd catheter. Surgical complications in the two study groups: catheter obstruction 0 (0%) 1 (6. 7%), catheter migration 0 (0%) 1 (6. 7%), dialysate leak 0 (0%) 2 (13. 4%), site infection 0 (0%) 1(6. 7%), peritonitis 1 (7. 1%) 5 (33. 3%), hernia 0 (0%) 2 (13. 4%).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00098 |
| MDR Report Key | 8537827 |
| 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 |