MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-23 for AUVARD VAGINAL SPECULA, 2 1/2 LBS., BLADE: 1 3/4"X * 500-147 manufactured by Bauer & Haeselbarth Gmbh.
[671976]
A medwatch report was received from the hosp stating "during procedure, weighted speculum lacerated pt's vagina, requiring suturing. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2007-00023 |
| MDR Report Key | 887617 |
| Date Received | 2007-07-23 |
| Date of Report | 2007-06-26 |
| Date of Event | 2007-05-24 |
| Date Facility Aware | 2007-06-11 |
| Report Date | 2007-06-26 |
| Date Added to Maude | 2007-08-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | AUVARD VAGINAL SPECULA, 2 1/2 LBS., BLADE: 1 3/4"X |
| Generic Name | SURGICAL INSTRUMENTS |
| Product Code | HDF |
| Date Received | 2007-07-23 |
| Model Number | * |
| Catalog Number | 500-147 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 865130 |
| Manufacturer | BAUER & HAESELBARTH GMBH |
| Manufacturer Address | * * GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-23 |