MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-05 for SIGMA HYALURONIDASE POWDER * manufactured by Sigma-aldrich.
[18911617]
Hyaluronidase powder from sigma was contaminated with yeast. Order#=h3506-5g, lot#=029k7001. Bottle was opened. A second bottle also showed contamination. We had two joint fluids that had yeast reported from the cytospin slide; however, cultures were negative. Cytospins were then performed using (1)sterile saline & (2)sterile saline mixed with hyaluronidase confirming the contamination. Sigma does not claim sterility of this product. We have not had any previous problems with this product. Company has recently switched packaging from glass to plastic bottles. Company is investigating.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1402240 |
| MDR Report Key | 1402240 |
| Date Received | 2009-06-05 |
| Date of Report | 2009-06-04 |
| Report Date | 2009-06-04 |
| Date Reported to FDA | 2009-06-05 |
| Date Added to Maude | 2009-06-16 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | SIGMA HYALURONIDASE POWDER |
| Generic Name | POWDER/REAGENT |
| Product Code | LEA |
| Date Received | 2009-06-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIGMA-ALDRICH |
| Manufacturer Address | P.O. BOX 14508 ST. LOUIS MO 63178 US 63178 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-05 |