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 2016-01-14 for SURESOUND SOUND12 manufactured by .
[35965350]
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. Mfg date: 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
[35965351]
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report# 1222780-2016-00010. It was reported a physician attempted to perform a novasure endometrial ablation on (b)(6) 2015 and received three unsuccessful cavity integrity assessment (cia) tests. The physician then "viewed the cavity via hysteroscopy and noted a postural perforation". The patient was taken the emergency room (er) for monitoring and then she underwent a hysterectomy. The patient was discharged home on (b)(6) 2015 and is doing "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00009 |
| MDR Report Key | 5366455 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-01-14 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-12-15 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2016-01-14 |
| 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 | MR. CRAIG CALLAHAN |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638859 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESOUND |
| Generic Name | UTERINE SOUNDING DEVICE |
| Product Code | HHM |
| Date Received | 2016-01-14 |
| Model Number | NA |
| Catalog Number | SOUND12 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-14 |