MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-04-14 for GOLDSTEIN SONOHYSTEROGRAPHY CATHETER N/A J-GSHC-532600 manufactured by Cook Inc.
[42640100]
(b)(4). This event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[42640101]
According to the initial reporter, the patient had a natural miscarriage at the end of (b)(6) 2015. At first, pills were used in an attempt to finish expelling tissue from the miscarriage. The patient continued to have cramping. The patient saw a physician at an obgyn office and a procedure was performed on (b)(6) 2016; which included an ultrasound and flushing with a catheter. The patient continued to have sharp pain, unlike that experienced with miscarriage or menstrual cramping. On (b)(6) 2016, a rubber acorn like part came out of the patient and into her underwear while she was menstruating. The patient went to the emergency room where it was confirmed with ultrasound that her anatomy seemed fine. No section of any device was detected inside of the patient during the ultrasound. The patient is reported to have continued experiencing sharp pain after the acorn had come out. The reporter states that the pain is a 6 on a scale of 1 to 10 and that the pain is worse when her bladder is full. The patient's mother is concerned that her daughter's pain could be caused by a part of a device continuing to remain inside her daughter's body; however, there is no evidence of this. There is no evidence that a section of the device remains inside the patient's body. The patient did require an additional ultrasound procedure due to this occurrence. According to the initial reporter, the patient did experience the adverse effect of sharp pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00246 |
| MDR Report Key | 5576007 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-04-14 |
| Date of Report | 2016-03-31 |
| Date of Event | 2016-03-19 |
| Date Facility Aware | 2016-03-19 |
| Date Mfgr Received | 2016-03-31 |
| Date Added to Maude | 2016-04-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLDSTEIN SONOHYSTEROGRAPHY CATHETER |
| Generic Name | HFF ASPIRATOR, ENDOMETRIAL |
| Product Code | HFF |
| Date Received | 2016-04-14 |
| Model Number | N/A |
| Catalog Number | J-GSHC-532600 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-14 |