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 2014-05-28 for SURESOUND SOUND12 manufactured by Hologic.
[4620614]
Note: this report pertains to the second of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report # 1222780-2014-00081. It was reported that a physician performed a novasure endometrial ablation on (b)(6) 2014 and received an unsuccessful cavity integrity assessment (cia) test. The physician performed a hysteroscopy and noted a uterine perforation. The patient was transferred to a hospital and a physician "put a stitch in the 5mm perforation". The patient was admitted into the hospital as she opted to have a hysterectomy. The hysterectomy was completed and the patient was discharged on (b)(6) 2014. A hysteroscopy and dilation (not hologic devices) were performed prior to the attempted ablation. It is not known when this perforation occurred or what instruments may have been the cause.
Patient Sequence No: 1, Text Type: D, B5
[12062721]
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
| Report Number | 1222780-2014-00080 |
| MDR Report Key | 3853487 |
| Report Source | 05,06,07 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-04-28 |
| Date of Event | 2014-04-28 |
| Date Mfgr Received | 2014-04-28 |
| Date Added to Maude | 2014-06-09 |
| 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 |
| 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 | 2014-05-28 |
| Model Number | NA |
| Catalog Number | SOUND12 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2014-05-28 |