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 2013-04-24 for SURESOUND SOUND12 manufactured by Hologic.
[18624825]
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, mfr's report number: 1222780-2013-00074. On (b)(6) 2013, the physician performed an uneventful novasure endometrial ablation. On (b)(6) 2013, it was reported the patient returned to the hospital complaining of "a lot of pain. The patient had a fever of 101 degree fahrenheit". A computed tomography (ct) scan revealed "no free air" and "no injury". The patient was then discharged home on amoxicillin.
Patient Sequence No: 1, Text Type: D, B5
[18760416]
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) and sterile lot 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) other adverse events: the following adverse event could occur or have been reported in association with the use of the novasure system: infection or sepsis. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2013-00073 |
| MDR Report Key | 3082961 |
| Report Source | 05,06,07 |
| Date Received | 2013-04-24 |
| Date of Report | 2013-03-25 |
| Date of Event | 2013-03-25 |
| Date Facility Aware | 2013-03-25 |
| Date Mfgr Received | 2013-03-25 |
| Date Added to Maude | 2013-04-30 |
| 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, MGR |
| 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 | 2013-04-24 |
| 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 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-24 |