MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-17 for COLLECTION DEVICE manufactured by Becton Dickinson.
[1002163]
When collecting a vaginal specimen, collection device end sponge-like swab came off collection device came off and entered patient's cervix. Date of use: 2008. Diagnosis: culture collection (screen).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009400 |
| MDR Report Key | 1275430 |
| Date Received | 2008-12-17 |
| Date of Report | 2008-12-15 |
| Date of Event | 2008-12-10 |
| Date Added to Maude | 2009-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | COLLECTION DEVICE |
| Product Code | HHT |
| Date Received | 2008-12-17 |
| Lot Number | 8158381 |
| Device Expiration Date | 2010-07-31 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-12-17 |