MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-22 for LOW CA 1.5 PERCENT 2L/2L UB DIANEAL manufactured by Baxter.
[98116400]
Mycobacterium chelonae-abscessus infection of peritoneal dialysis exit catheter. Therapy start date: (b)(6) 2017. Therapy end date: (b)(6) 2018. Diagnosis or reason for use: peritoneal dialysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074708 |
| MDR Report Key | 7211948 |
| Date Received | 2018-01-22 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-12-05 |
| Date Added to Maude | 2018-01-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LOW CA 1.5 PERCENT 2L/2L UB DIANEAL |
| Generic Name | DIALYSATE |
| Product Code | KPF |
| Date Received | 2018-01-22 |
| ID Number | 5B9766 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-22 |