MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-06 for MINNTECH 35-8208-7 manufactured by Minntech Corp..
[14127]
Facility alleges that blood port and dialysate port caps are different to remove, once in place. This has resulted in formaldehyde spills, causing formaldehyde reaction in clinic employee. Symptoms include burning and itching of skin and eyes and headaches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1994-00113 |
| MDR Report Key | 19308 |
| Date Received | 1994-06-06 |
| Date of Report | 1994-05-20 |
| Date of Event | 1994-05-02 |
| Date Facility Aware | 1994-05-16 |
| Report Date | 1994-05-20 |
| Date Reported to FDA | 1994-05-20 |
| Date Reported to Mfgr | 1994-05-20 |
| Date Added to Maude | 1995-02-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINNTECH |
| Generic Name | VENTABLE BLOOD PORT CAP |
| Product Code | KPP |
| Date Received | 1994-06-06 |
| Catalog Number | 35-8208-7 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19224 |
| Manufacturer | MINNTECH CORP. |
| Manufacturer Address | 14904 28TH AVENUE NORTH PLYMOUTH MN 55447 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-06-06 |