MAUDE Adverse Event Report: COOK INC GOLDSTEIN SONOHYSTEROGRAPHY CATHETER; HFF ASPIRATOR, ENDOMETRIAL

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 03/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This event is currently under investigation.

Event Description

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.

• Brand Name: GOLDSTEIN SONOHYSTEROGRAPHY CATHETER
• Type of Device: HFF ASPIRATOR, ENDOMETRIAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5576007
• MDR Text Key: 42640100
• Report Number: 1820334-2016-00246
• Device Sequence Number: 1
• Product Code: HFF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: J-GSHC-532600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/19/2016
• Event Location: Other
• Date Manufacturer Received: 03/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other