MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for ER-SPEC/OFFICE-SPEC manufactured by Obp Corporation.
[184643592]
Patient was admitted for labor. The lighted speculum was utilized on the patient for a gynecological exam. During a separate exam a small firm piece of plastic consistent with the tab from lighted speculum was found in lower vagina and removed. This event poses a risk for a potential retained foreign object. No harm came to this patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9871262 |
| MDR Report Key | 9871262 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-22 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-03-24 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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/OFFICE-SPEC |
| Generic Name | SPECULUM, VAGINAL, NONMETAL |
| Product Code | HIB |
| Date Received | 2020-03-24 |
| Lot Number | 19E1102Z |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBP CORPORATION |
| Manufacturer Address | 360 MERRIMACK STREET BUILDING 9 LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |