MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-21 for ER-SPEC C020120-1 manufactured by Obp Corporation.
[26264101]
Patient Sequence No: 1, Text Type: N, H10
[26264102]
The dr. Was performing a vaginal exam and inserted the speculum without difficulty and attempted to open the speculum and it broke at the clear u shaped piece. Another exam was attempted with a new speculum and it broke in the same area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5090433 |
| MDR Report Key | 5090433 |
| Date Received | 2015-09-21 |
| Date of Report | 2015-09-16 |
| Date of Event | 2015-09-11 |
| Report Date | 2015-09-16 |
| Date Reported to FDA | 2015-09-16 |
| Date Reported to Mfgr | 2015-09-16 |
| Date Added to Maude | 2015-09-21 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ER-SPEC |
| Generic Name | SPECULUM, VAGINAL, NONMETAL |
| Product Code | HIB |
| Date Received | 2015-09-21 |
| Model Number | C020120-1 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBP CORPORATION |
| Manufacturer Address | 360 MERRIMACK STREET BLDG. 9, FLOOR MEZZANINE LAWRENCE, MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-21 |