MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for SURESOUND SOUND12-923001-01 manufactured by Hologic, Inc.
[59975018]
Lot number of the suresound not provided by the complainant, therefore the expiration date is not known. The suresound is not being returned therefore, a failure analysis of the complaint device can not be completed. Lot number of the suresound not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review could not be conducted for the suresound as a lot number was not provided by the complainant. According to the instructions for use (ifu) adverse events: potential adverse events include, but are not limited to perforation of the uterine wall (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59975019]
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report# 1222780-2016-00270. It was reported the physician attempted to perform a novasure endometrial ablation on (b)(6) 2016 and received several unsuccessful cavity integrity assessment (cia) tests using two disposable devices. After the physician removed the second device, a hysteroscopy was performed and the physician saw a small perforation. No intervention was required. The procedure was aborted and the patient was discharged home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00273 |
| MDR Report Key | 6103664 |
| Date Received | 2016-11-15 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-10-07 |
| Date Mfgr Received | 2016-10-18 |
| Date Added to Maude | 2016-11-15 |
| 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 | MS. SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURESOUND |
| Generic Name | UTERINE SOUNDING DEVICE |
| Product Code | HHM |
| Date Received | 2016-11-15 |
| Catalog Number | SOUND12-923001-01 |
| Operator | PHYSICIAN |
| 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 | 2016-11-15 |