MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-21 for DISPOSABLE VAGINAL SPECULUM DX010M 1126155 manufactured by Unk.
[70909814]
Md was completing a pelvic exam. As md attempted to remove the speculum from the patient, the speculum cracked, a piece of plastic broke off, and the piece flew into the md's right eye. Md was treated for a corneal abrasion. Mfr name: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068650 |
| MDR Report Key | 6431792 |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-01-12 |
| Date Added to Maude | 2017-03-24 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DISPOSABLE VAGINAL SPECULUM |
| Generic Name | DISPOSABLE VAGINAL SPECULUM |
| Product Code | HIB |
| Date Received | 2017-03-21 |
| Returned To Mfg | 2017-03-17 |
| Model Number | DX010M |
| Catalog Number | 1126155 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-21 |