MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-11-05 for GROCOTTS METHENAMINE SILVER STAIN * S7440-8 (87008) manufactured by Richard-allan Scientific.
[18825894]
Bronchial fluid sent to cytology was contaminated during processing with fungal elements. Pt results were released: stating "positive for fungus". The next day, another specimen had the same fungal elements, the slides were compared and similarities lead to the conclusion that this was a contaminant. Through the next several weeks, a thorough investigation as to the source of the contaminant was conducted. Eventually it was discovered that a purchased stain product was being delivered to hospital already contaminated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 359816 |
| MDR Report Key | 359816 |
| Date Received | 2001-11-05 |
| Date of Report | 2001-11-05 |
| Date of Event | 2001-06-21 |
| Date Facility Aware | 2001-06-21 |
| Report Date | 2001-11-05 |
| Date Reported to FDA | 2001-11-05 |
| Date Reported to Mfgr | 2001-09-21 |
| Date Added to Maude | 2001-11-15 |
| 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 | GROCOTTS METHENAMINE SILVER STAIN |
| Generic Name | FAST GREEN STAIN USED TO PROCESS CYTOLOGY SPECIMENS |
| Product Code | HYC |
| Date Received | 2001-11-05 |
| Model Number | * |
| Catalog Number | S7440-8 (87008) |
| Lot Number | 1E31A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 348997 |
| Manufacturer | RICHARD-ALLAN SCIENTIFIC |
| Manufacturer Address | 225 PARSONS STRRET KALAMAZOO MI 490073538 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2001-11-05 |