MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-12-30 for RENALIN manufactured by Minntech Corp..
[342583]
Pt complained of burning sensation at the venous return at the beginning of treatment. Pt also stated they felt like they were going blind. Pt care people thought it was a renalin reaction so treatment was immediately stopped. Symptoms went away as soon as treatment was stopped. Staff reported the dialyzer showed blood to be darker on one end than on the other. Pt was reinitiated on a dry pack dialyzer and treatment was completed without further incident. No hospitalization was required. Pt doing fine, with no ill effects being reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2004-00037 |
| MDR Report Key | 562610 |
| Report Source | 05,06 |
| Date Received | 2004-12-30 |
| Date of Report | 2004-12-29 |
| Date of Event | 2004-12-03 |
| Date Facility Aware | 2004-12-03 |
| Report Date | 2004-12-29 |
| Date Mfgr Received | 2004-12-03 |
| Date Added to Maude | 2005-01-04 |
| 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 Street | 14605 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533300 |
| Manufacturer G1 | MINNTECH CORPORATION |
| Manufacturer Street | 14605 28TH AVENUE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENALIN |
| Generic Name | COLD STERILANT |
| Product Code | LIF |
| Date Received | 2004-12-30 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| 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 | 552337 |
| Manufacturer | MINNTECH CORP. |
| Manufacturer Address | 14605 28TH AVE. NORTH MINNEAPOLIS MN 55447 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-12-30 |