MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-20 for MYOSURE ROD LENS HYSTEROSCOPE 40-250 manufactured by Hologic, Inc.
[176867164]
Serial number of the device not provided by the complainant, therefore the expiration date is not known. The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed. Serial number of the device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the device as the identification numbers were not provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[176867165]
It was reported that on an unknown date, the patient underwent a fibroid/polyp removal procedure. The physician then saw the patient for follow-up 2 weeks post procedure and saw some marks in her vaginal canal that looked unusual, suspected thermal injury. In follow up, the physician said "i'm not convinced they are burns. Maybe abrasions from vaginal manipulation with the speculum. They were 2cm brownish plaques on the anterior fornices of the vagina and on the external cervical. " when asked about thermal injury inside the uterine cavity, the physician said "i do not believe there were any 'burns' to the endometrial cavity. " the patient reported no discomfort but persistent vaginal discharge. No additional details available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2020-00016 |
| MDR Report Key | 9608461 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-20 |
| Date of Report | 2019-12-31 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KELSEA LYVER |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082636130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOSURE ROD LENS HYSTEROSCOPE |
| Generic Name | UTERINE HYSTEROSCOPE |
| Product Code | HIH |
| Date Received | 2020-01-20 |
| Model Number | 40-250 |
| Catalog Number | 40-250 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-20 |