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 2013-12-11 for SURESOUND SOUND12 manufactured by Hologic.
[4124128]
Note: this report pertains to the second of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report# 1222780-2013-00225. It was reported a physician performed a successful endometrial ablation. A couple days post-procedure the patient presented to the emergency room (er) with a "headache and temperature of 101. 9 degrees fahrenheit at home". There was "non-specific findings" and the patient was discharged an oral antibiotics (flagyl-metronidazole and doryx-doxycycline hyclate) for "presumed endometritis. " the patient returned to the emergency room one day later with a "worsening migraine headache and fever at home". There was "no uterine tenderness. " the physician administered pain medication and the patient was discharged home. Two days later the patient returned to the emergency room with "similar complaints and was admitted to the hospital. Her [white blood cell] wbc [count] was low and she her platelet count was 50,000 consistent with sepsis. Her genito-urinary culture and peripheral blood cultures were positive for group b streptococcus (gbs). There was still no uterine tenderness. She developed a septic ankle joint which also grew out gbs. " the patient was discharged home and is "receiving physical therapy for the ankle. "
Patient Sequence No: 1, Text Type: D, B5
[11452448]
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 manufacturer date is not known. Device history record (dhr) review and sterile lot 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 | 1222780-2013-00224 |
| MDR Report Key | 3535206 |
| Report Source | 05,06,07 |
| Date Received | 2013-12-11 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-10-31 |
| Date Facility Aware | 2013-10-31 |
| Date Mfgr Received | 2013-11-11 |
| 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, MANAGER |
| 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 | 2013-12-11 |
| Model Number | NA |
| Catalog Number | SOUND12 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2013-12-11 |