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 2019-04-12 for DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..
[141907736]
Title acute peritoneal dialysis in the newborn period: a 7-year single-center experience at tertiary neonatal intensive care unit in turkey source am j perinatol, volume 31, 2014 (335-338) date of publication: 28 june 2013. If information is provided in the future, a supplemental report will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141907797]
According to literature source of study performed between 2005 and 2011, pd (peritoneal dialysis) catheters were placed in 77 neonates. 52. 2% of patients had hyperglycemia, 19. 4% of patients had leakage from catheter entrance, 14. 9% of patients had peritonitis, 4. 5% of patients had catheter obstruction, 4. 5% of patients had bleeding when inserting the catheter, 3% of patient had catheter exit site infection, and 1. 5% of patient had bowel perforation. The catheters used neonatal straight or pigtail single cuff catheter. Of patients who had peritonitis, two patients required removal of catheter and two patients with fungal peritonitis responded to removal of the peritoneal catheter and a 3-week course of intravenous amphotericin. Acute peritoneal dialysis and neonatal intensive care unit: nilay hakan, md, 2012, 2013, june 28.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00088 |
| MDR Report Key | 8511650 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-18 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2019-04-12 |
| 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 | 2019-04-12 |
| Model Number | DIALYSIS UNKNOWN |
| Catalog Number | DIALYSIS UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-04-12 |