MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-12-14 for SURESOUND SOUND12-923001-01 manufactured by Hologic.
[17445172]
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report # 1222780-2012-00275. Following an unsuccessful cavity integrity assessment (cia) test during a novasure endometrial ablation the physician did a hysteroscopy and saw a uterine perforation at the "center of the fundus and anterior". The procedure was aborted. No intervention required. The patient is "doing well" and was discharged home.
Patient Sequence No: 1, Text Type: D, B5
[17709348]
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 event include, but are not limited to perforation of the uterine wall. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2012-00276 |
| MDR Report Key | 2879126 |
| Report Source | 05,06,07 |
| Date Received | 2012-12-14 |
| Date of Report | 2012-11-14 |
| Date of Event | 2012-10-01 |
| Date Mfgr Received | 2012-11-14 |
| Date Added to Maude | 2012-12-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG CALLAHAN, MGR. |
| 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 |
| Product Code | HHM |
| Date Received | 2012-12-14 |
| Model Number | NA |
| Catalog Number | SOUND12-923001-01 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-14 |