MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-06-02 for RENALIN manufactured by Minntech Corporation.
[20891963]
4 patients experienced reactions on initiation of dialysis. Symptoms included numbness of the lips, swelling of the jaw, hypotension, shortness of breath, diarrhea and back pain. 1 patient was removed from dialysis and sent to the hospital. 3 remaining patients were taken off of dialysis and sent home. Patient sent to the hospital er was treated and released. This patient did not require hospitalization. All 4 patients doing well with no ill effects reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2003-00007 |
| MDR Report Key | 463917 |
| Report Source | 05,06 |
| Date Received | 2003-06-02 |
| Date of Report | 2003-05-30 |
| Date of Event | 2003-05-05 |
| Date Facility Aware | 2003-05-05 |
| Report Date | 2003-05-30 |
| Date Mfgr Received | 2003-05-05 |
| Date Added to Maude | 2003-06-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 14605 28TH AVENUE, NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENALIN |
| Generic Name | COLD STERILANT |
| Product Code | LIF |
| Date Received | 2003-06-02 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 452861 |
| Manufacturer | MINNTECH CORPORATION |
| Manufacturer Address | 14605 28TH AVE. NORTH MINNEAPOLIS MN 55447 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2003-06-02 |