MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2014-06-21 for SURESOUND SOUNDPRD-02620 manufactured by Hologic.
[4647719]
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report #1222780-2014-00099. It was reported that a physician performed a novasure endometrial ablation on (b)(6) 2014. The physician received an unsuccessful cavity integrity assessment (cia) test. The physician removed the disposable device and rechecked the patient's measurements and noticed the hysteroscope traveling "far into the cavity-noted". The physician perforated and aborted the procedure. The patient was admitted into the hospital overnight for observation. The physician prescribed antibiotics for seven days and norethisterone (brand name unknown) to assist with the patient's menorrhagia. 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 instrument may have been the cause.
Patient Sequence No: 1, Text Type: D, B5
[11928445]
Lot number of the sure-sound not provided by the complainant, therefore the expiration date is unknown. The sure-sound is not being returned therefore, a failure analysis of the complaint device can not be completed. Lot number of the sure-sound not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review could not be conducted for the sure-sound as a lot number was not provided by complainant. Reference internal complaint cc#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2014-00098 |
| MDR Report Key | 3901516 |
| Report Source | 04,05,06 |
| Date Received | 2014-06-21 |
| Date of Report | 2014-05-23 |
| Date of Event | 2014-05-15 |
| Date Mfgr Received | 2014-05-23 |
| Date Added to Maude | 2014-07-01 |
| 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 | 2014-06-21 |
| Model Number | NA |
| Catalog Number | SOUNDPRD-02620 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-06-21 |