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 2013-12-06 for SURESOUND SOUND 12 manufactured by Hologic.
[4118053]
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, mfr's report number: 1222780-2013-00226. It was reported a physician performed an uneventful novasure endometrial ablation on (b)(6) 2013 and the pt was discharged home. The following day the patient was complaining of discomfort and low grade fever. The physician instructed the patient be seen for a follow up. The physician performed an ultrasound which did not reveal any abnormalities. "there was no fluid in her cavity" and cultures were drawn. The physician believes the patient has endometritis. Ampicillin was administered and the patient was discharged home. It was reported on (b)(6) 2013, the patient's cultures were negative. The patient was diagnosed with "clinically endometritis". There were no problems and the patient is "doing wonderful".
Patient Sequence No: 1, Text Type: D, B5
[11454562]
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 cannot be completed. Lot number of the suresound not provided by the complainant, therefore, the mfr 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2013-00209 |
| MDR Report Key | 3535653 |
| Report Source | 05,06,07 |
| Date Received | 2013-12-06 |
| Date of Report | 2013-11-08 |
| Date of Event | 2013-11-07 |
| Date Facility Aware | 2013-11-08 |
| Date Mfgr Received | 2013-11-08 |
| Date Added to Maude | 2013-12-26 |
| 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 |
| Manufacturer G1 | HOLOGIC |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESOUND |
| Product Code | HHM |
| Date Received | 2013-12-06 |
| Model Number | NA |
| Catalog Number | SOUND 12 |
| 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 | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-06 |