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 2015-12-22 for SURESOUND SOUND12 manufactured by .
[34179203]
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
[34179204]
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report# 1222780-2014-00240. It was reported that a physician attempted to perform a novasure endometrial ablation on (b)(6) 2015 and was having difficulty opening the electrode array inside the patient. The physician eventually did open the array too far and suspected a perforation. The procedure was aborted. A post hysteroscopy was performed, but there was no visualization, as the physician was unable to hold distension. No intervention was required and the patient was discharged home. Dilatation (not hologic device) was performed prior to the attempted ablation. It is not known when this perforation occurred or what instrument may have been the cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2015-00239 |
| MDR Report Key | 5320512 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-12-02 |
| Date Mfgr Received | 2015-12-02 |
| Date Added to Maude | 2015-12-22 |
| 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 | 2015-12-22 |
| 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 | 2015-12-22 |