MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-31 for * 153 manufactured by Busse Hospital Disposables.
[3108037]
The patient was in the operating suite. The uterus was sounded and then suction curette placed to the fundus and then attached to suction. The tubing itself was collapsing and therefore technique was changed to sharp curettage. Sharp curettage was done to verify uterus was empty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2900753 |
| MDR Report Key | 2900753 |
| Date Received | 2012-12-31 |
| Date of Report | 2012-12-31 |
| Date of Event | 2012-12-28 |
| Report Date | 2012-12-31 |
| Date Reported to FDA | 2012-12-31 |
| Date Added to Maude | 2013-01-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | CANNULA, SUCTION, UTERINE |
| Product Code | HGH |
| Date Received | 2012-12-31 |
| Model Number | * |
| Catalog Number | 153 |
| Lot Number | 66667-2 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BUSSE HOSPITAL DISPOSABLES |
| Manufacturer Address | 75 ARKAY DRIVE PO BOX 11067 HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-31 |