MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-04-23 for CULTURETTE TOXIN CD 4954004 manufactured by Becton Dickinson.
[140184]
A 79 year old female was admitted to the hospital for unknown reasons. During the course of hospitalization she was placed on multiple, broad-spectrum antibiotics for suspected sepsis. At some point she developed diarrhea, that was visually bloody at times. The source of the blood in her stools was never determined and the pt subsequently had a near-total colectomy and expired thereafter. She had five stool specimens taken over a period of four days which were tested with the device. All results were reported as negative. The pathology of the excised colon showed "massive pseudomembranous colitis," without colonic perforations or evidence of toxic megacolon. There was never any confirmation by any other method that clostridium difficile was the etiologic agent for the pseudomembranous colitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-1999-00002 |
| MDR Report Key | 220327 |
| Report Source | 05 |
| Date Received | 1999-04-23 |
| Date of Report | 1999-03-24 |
| Date of Event | 1999-03-24 |
| Date Mfgr Received | 1999-03-24 |
| Device Manufacturer Date | 1998-11-01 |
| Date Added to Maude | 1999-04-27 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CULTURETTE TOXIN CD |
| Generic Name | RAPID IMMUNOASSAY TEST |
| Product Code | LLH |
| Date Received | 1999-04-23 |
| Model Number | NA |
| Catalog Number | 4954004 |
| Lot Number | 1000C9FGIF |
| ID Number | NA |
| Device Expiration Date | 1999-09-17 |
| 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 | 213683 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | BLVD LUIS DONALDO COLOSIO #3100 NOGALES, SONORA * |
| Baseline Brand Name | CULTURETTE BRAND TOXIN CD |
| Baseline Generic Name | REAGENTS, CLOSTRIDIUM DIFFICILE TOXIN |
| Baseline Model No | NA |
| Baseline Catalog No | 4954004 |
| Baseline ID | 1000C9FG1F |
| Baseline Device Family | MICROORGANISM DIFFERENTIATION & IDENTIFICATION DEVICE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K925329 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1999-04-23 |