MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-11 for MEDLINE SPECULUM manufactured by Medline.
[89254002]
Pt was having a vaginal exam using speculum. Top piece of speculum broke at base. Top piece removed from vaginal canal without injury or incident. Each speculum comes in individual package. Lot no: 17qb5793. Reorder #(b)(4), exp 11/30/2020, mfr - medline.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072700 |
| MDR Report Key | 6940442 |
| Date Received | 2017-10-11 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-10-06 |
| Date Added to Maude | 2017-10-11 |
| 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 | MEDLINE SPECULUM |
| Generic Name | MEDLINE SPECULUM |
| Product Code | HIB |
| Date Received | 2017-10-11 |
| Lot Number | 17QB5793 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |