MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-08-30 for NEPHRETECT 5000 manufactured by Alden Scientific, Inc..
[23459]
Pt was prepared for dialysis and at the onset of dialysis experienced a reaction, and dialysis was discontinued. Typical symptoms of rebound syndrome occurred with a drop in blood pressure, dizziness, and pt lapsed into a semi-conscious state. Benadryl was administered and within 4-5 minutes, symptoms had subsided, but pt was admitted into hosp for observation. No further developments occurred. In discussing the incident with the chief technician it was believed that the rinsing procedure was not fully followed. Chief technician tested the lot to determine its efficacy and it proved to be within specs. Co will test several ampules from the effected lot and submit the results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221361-1996-00001 |
| MDR Report Key | 40919 |
| Report Source | 06 |
| Date Received | 1996-08-30 |
| Date of Report | 1996-08-29 |
| Date of Event | 1996-08-28 |
| Date Mfgr Received | 1996-08-28 |
| Device Manufacturer Date | 1996-07-01 |
| Date Added to Maude | 1996-10-07 |
| 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 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEPHRETECT |
| Generic Name | FORMALDEHYDE DETECTOR |
| Product Code | HZT |
| Date Received | 1996-08-30 |
| Model Number | NA |
| Catalog Number | 5000 |
| Lot Number | 06728 |
| ID Number | * |
| Device Expiration Date | 1998-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 42007 |
| Manufacturer | ALDEN SCIENTIFIC, INC. |
| 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. Other | 1996-08-30 |