MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-12-20 for COPPER SULFATE SOLUTION 94061/71 manufactured by Emd Chemicals Inc..
[278084]
Patient came to blood donor facility to donate blood, was tested routinely, and passed as able to donate. One pint blood was taken. Patient became ill and experienced weakness, dizziness, and nausea. Donor was taken by ambulance to the hospital and was released two days later. The donor hematocrit performed in hospital was found to be low. Blood donor lab retested unit of donated blood using same lot of copper sulfate solution as previously used. This test also gave low unacceptable reading. Both initial qc and retests by lab on the lot of copper sulfate solution showed it to be within specifications. Blood donor facility found no problems with use of the lot of solution in other patient tests. It was concluded by both user facility and manufacturer that there was no defect in the copper sulfate solution used in the testing of the patient. It is unlikely that the copper sulfate solution contributed to the adverse event. It is possible that a user error occurred in handling of the portion of the solution used, the patient sample, or the evaluation of the test result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2244894-2002-00001 |
| MDR Report Key | 433890 |
| Report Source | 05,06 |
| Date Received | 2002-12-20 |
| Date of Report | 2002-06-18 |
| Date of Event | 2002-05-19 |
| Date Mfgr Received | 2002-06-18 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2002-12-26 |
| 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 | ANNA BENTLEY, VICE-PRESIDENT |
| Manufacturer Street | 480 S. DEMOCRAT ROAD |
| Manufacturer City | GIBBSTOWN NJ 08027 |
| Manufacturer Country | US |
| Manufacturer Postal | 08027 |
| Manufacturer Phone | 8564236300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPPER SULFATE SOLUTION |
| Generic Name | COPPER SULFATE SOLUTION FOR SPECIFIC GRAVITY TESTING OF BLOO |
| Product Code | JPH |
| Date Received | 2002-12-20 |
| Model Number | NA |
| Catalog Number | 94061/71 |
| Lot Number | 2050 |
| ID Number | * |
| Device Expiration Date | 2003-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 422845 |
| Manufacturer | EMD CHEMICALS INC. |
| Manufacturer Address | 480 S DEMOCRAT ROAD GIBBSTOWN NJ 08027 US |
| Baseline Brand Name | COPPER SULFATE SOLUTION |
| Baseline Generic Name | COPPER SULFATE SOLUTION |
| Baseline Catalog No | 94061/71 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2002-12-20 |