MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-01 for DYNAREX manufactured by Dynarex.
[2736948]
After the speculum was inserted into the vagina, small piece of plastic broke off of the speculum as the nurse was beginning to open the speculum in the vagina. This occurred on (b)(6) 2012. She was hit on the chin during one occurrence and on the cheek during the other occurrence. Her skin was not broken, she was wearing glasses and ppe. The client was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026378 |
| MDR Report Key | 2682378 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-07-13 |
| Date of Event | 2012-06-12 |
| Date Added to Maude | 2012-08-07 |
| 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 | 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 | DYNAREX |
| Generic Name | MEDIUM VAGINAL SPECULUM |
| Product Code | HIB |
| Date Received | 2012-08-01 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNAREX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-01 |