FDA.reportPublic FDA data

MAUDE MDR 8233031

MDR report key
8233031
Report number
2210968-2019-78304
Event key
0
Event type
3
Date received
2019-01-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DARLENE KYLE
Address
P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US
Phone
908-908-9082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GYNECARE MORCELLEX UNKNOWN PRODUCTLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)ETHICON INC.HETGMORCUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-1001. R

Event Narratives#

N

Patient 1

(B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IT IS UNKNOWN IF THE ACTUAL DEVICE USED IN THIS PATIENT PROCEDURE WAS IN FACT AN ETHICON MORCELLATOR. THE EVENT INVESTIGATION IS ONGOING. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE DEVICE INFORMATION FOR USE UNDER PRECAUTIONS STATES" CAUTION: THE USE OF A LAPAROSCOPIC TISSUE EXTRACTION BAG IS RECOMMENDED FOR THE MORCELLATION OF MALIGNANT TISSUE OR TISSUE SUSPECTED OF BEING MALIGNANT AND FOR TISSUE THAT THE PHYSICIAN CONSIDERS TO BE POTENTIALLY HARMFUL WHEN DISSEMINATED IN A BODY CAVITY. AS MORCELLATION MAY AFFECT ENDOMETRIAL PATHOLOGIC EXAMINATION, PREOPERATIVE EVALUATION OF THE ENDOMETRIUM SHOULD BE CONSIDERED. SHOULD MALIGNANCY BE IDENTIFIED, USE OF THE GYNECARE MORCELLEX? TISSUE MORCELLATOR MAY LEAD TO DISSEMINATION OF MALIGNANT TISSUE.

D

Patient 1

IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2007 DUE TO UTERINE FIBROIDS AND BLEEDING AND THE UNKNOWN MORCELLATOR WAS USED. IT WAS ALSO REPORTED THAT THE USE OF THE MORCELLATOR LEAD TO THE SPREAD OF UNDETECTED LEIOMYOSARCOMA. NO ADDITIONAL INFORMATION IS AVAILABLE.