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 2018-04-27 for SURESOUND SOUND12-923001-01 manufactured by Hologic, Inc..
[106790935]
Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known. The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed. Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant. Internal reference complaint: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106790936]
Note: this report pertains to the first of three hologic devices used in the same procedure. See associated medwatch, manufacturer's report# 1222780-2018-00080 & 1222780-2018-00081. It was reported the physician attempted to perform a (b)(6) endometrial ablation on (b)(6) 2018 and the physician received several cavity integrity assessment (cia) tests using two disposable arrays. The physician then performed a hysteroscopy and visualized a perforation in the "tubal ostia area". The procedure was aborted. It is unknown if intervention was required.
Patient Sequence No: 1, Text Type: D, B5
[109934953]
Device history record (dhr) review was conducted for the identified lot number and serial number of the disposable device. No abnormalities were found related to the reported information. This device passed final testing prior to release. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2018-00082 |
| MDR Report Key | 7469967 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-27 |
| Date of Report | 2018-03-30 |
| Date of Event | 2018-03-30 |
| Date Mfgr Received | 2018-04-27 |
| Date Added to Maude | 2018-04-27 |
| 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 | 3 |
| Brand Name | SURESOUND |
| Generic Name | UTERINE SOUNDING DEVICE |
| Product Code | HHM |
| Date Received | 2018-04-27 |
| Model Number | NA |
| Catalog Number | SOUND12-923001-01 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-04-27 |