MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-05-17 for NEPHRETECT UNK 5000 manufactured by Alden, A Div Of Metrex Research Corp.
[206438]
A healthcare worker from the kidney center reported that while 2 pts were hooked up to dialysis treatment, they simultaneously experienced symptoms of formaldehyde exposure (ie, swollen lips, difficulty breathing). The dialysis treatments were immediately discontinued and the pts received medical treatment from the nurses on-site. The healthcare worker stated that prior to turning on the dialysis machines, nephretect was used to detect formaldehyde residual. No residual was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221361-2001-00002 |
| MDR Report Key | 333857 |
| Report Source | 05 |
| Date Received | 2001-05-17 |
| Date of Report | 2001-04-18 |
| Date of Event | 2001-04-18 |
| Date Mfgr Received | 2001-04-18 |
| Device Manufacturer Date | 2000-12-01 |
| Date Added to Maude | 2001-05-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WENDY URTEL |
| Manufacturer Street | 1717 WEST COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167425 |
| 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 | NEPHRETECT |
| Generic Name | FORMALDEHYDE TEST REAGENT |
| Product Code | HZT |
| Date Received | 2001-05-17 |
| Model Number | UNK |
| Catalog Number | 5000 |
| Lot Number | 00117 |
| ID Number | NA |
| Device Expiration Date | 2002-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 323221 |
| Manufacturer | ALDEN, A DIV OF METREX RESEARCH CORP |
| Manufacturer Address | 360 COLD SPRING AVE WEST SPRINGFIELD MA 01089 US |
| Baseline Brand Name | NEPHRETECT |
| Baseline Generic Name | FORMALDEHYDE TEST REAGENT |
| Baseline Model No | UNK |
| Baseline Catalog No | 5000 |
| Baseline ID | NA |
| Baseline Device Family | CHEMICAL INDICATOR |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K934066 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2001-05-17 |