MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-09-18 for CULTURETTE 4360210 manufactured by Becton Dickinson Microbiology Systems.
[24711]
Pledget adhered to swab prior to use. While collecting a throat culture, the pledget became detached from the swab and lodged in the pt's throat. The md removed the pledget with his finger.
Patient Sequence No: 1, Text Type: D, B5
[6077333]
Pledget adhered to swab prior to use. While collecting a throat culture, the pledget became detached from the swab and lodged in the pt's throat. The md removed the pledget with his finger.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 1119779-1996-00001 |
| MDR Report Key | 46092 |
| Report Source | 06 |
| Date Received | 1996-09-18 |
| Date of Report | 1996-09-12 |
| Date of Event | 1996-07-17 |
| Date Facility Aware | 1996-08-30 |
| Report Date | 1996-09-12 |
| Date Reported to FDA | 1996-08-30 |
| Date Mfgr Received | 1996-08-21 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 1996-11-05 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CULTURETTE |
| Generic Name | COLLECTION & TRANSPORT SYSTEM |
| Product Code | JSC |
| Date Received | 1996-09-18 |
| Model Number | NA |
| Catalog Number | 4360210 |
| Lot Number | 605045 |
| ID Number | NA |
| Device Expiration Date | 1999-05-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 46941 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-18 |
| 2 | 0 | 1996-09-18 |