MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-04 for SANI-SPEC 82329 manufactured by Leisegang Medical.
[17062240]
Rn experienced difficulty unlocking speculum for removal after exam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007175 |
| MDR Report Key | 1056864 |
| Date Received | 2008-06-04 |
| Date of Report | 2008-05-22 |
| Date of Event | 2008-05-22 |
| Date Added to Maude | 2008-06-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANI-SPEC |
| Generic Name | VAGINAL SPECULUM |
| Product Code | HDF |
| Date Received | 2008-06-04 |
| Model Number | 82329 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1025455 |
| Manufacturer | LEISEGANG MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-04 |