MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for SURESOUND NS2007 US manufactured by Hologic, Inc..
[23540375]
Patient Sequence No: 1, Text Type: N, H10
[23540376]
The suresound device would not work. It gave a different reading each time we attempted to self-test. It was unplugged and plugged in approximately 5 times and would give different width readings every time. It wasn't the machine generator that was failing, because we got another suresound device to use with the same machine generator and it worked fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5017617 |
| MDR Report Key | 5017617 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-07-07 |
| Date of Event | 2015-07-07 |
| Report Date | 2015-07-07 |
| Date Reported to FDA | 2015-07-07 |
| Date Reported to Mfgr | 2015-07-07 |
| Date Added to Maude | 2015-08-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESOUND |
| Generic Name | SOUND,UTERINE |
| Product Code | HHM |
| Date Received | 2015-08-20 |
| Catalog Number | NS2007 US |
| Lot Number | 15C03R |
| Device Expiration Date | 2016-04-03 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DR. MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-20 |