MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-18 for ER-SPEC SINGLE USE VAGINAL SPECULA * C020120-1 manufactured by Obp Medical.
[22262273]
Physician was performing an annual gynecological examination; upon trying to locate patient's cervix and applying necessary pressure to perform examination, the piece used to open the speculum broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4023019 |
| MDR Report Key | 4023019 |
| Date Received | 2014-08-18 |
| Date of Report | 2014-08-18 |
| Date of Event | 2014-08-14 |
| Report Date | 2014-08-18 |
| Date Reported to FDA | 2014-08-18 |
| Date Reported to Mfgr | 2014-08-20 |
| Date Added to Maude | 2014-08-20 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ER-SPEC SINGLE USE VAGINAL SPECULA |
| Generic Name | SPECULUM, VAGINAL, NONMETAL |
| Product Code | HIB |
| Date Received | 2014-08-18 |
| Model Number | * |
| Catalog Number | C020120-1 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBP MEDICAL |
| Manufacturer Address | 360 MERRIMACK ST BLDG 9, FLOOR MEZZANINE LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-18 |