MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-04-23 for PERITONEAL 8888423624 manufactured by Covidien Mfg Solutions S.a..
[145370058]
Title radiological insertion of tenckhoff catheters for peritoneal dialysis: a 1-year single-centre experience source clin kidney j, volume 7, 2014(23-26) date of publication: 23 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
[145370059]
According to the literature source of study performed over the 12-month period, after post-insertion of dialysis catheter(s) which led to complications such as; catheter migration(13. 3%) but only one required surgical intervention. Minor pain issues were noted (20%) and bleeding around the exit site requiring suturing (6. 7%). Majority of the patients experienced minor pain/discomfort.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00102 |
| MDR Report Key | 8541722 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2013-09-23 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-04-23 |
| 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 | PERITONEAL |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | FJS |
| Date Received | 2019-04-23 |
| Model Number | 8888423624 |
| Catalog Number | 8888423624 |
| 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 | 2019-04-23 |