FDA.reportPublic FDA data

MAUDE MDR 9887258

MDR report key
9887258
Report number
2210968-2020-02411
Event key
0
Event type
3
Date received
2020-03-27
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
KARA DITTY-BOVARD
Address
P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VICRYL ABS SUR SUT USP SYNSUTURE, ABSORBABLE, SYNTHETICETHICON INC.GAMNW2317MLBDZPQ0R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-270

Event Narratives#

N

Patient 1

(B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS WERE MADE TO OBTAIN THE DEVICE RETURN FOR EVALUATION. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE CONFIRM WHAT WAS THE INITIAL PROCEDURE? PATIENT PROCEDURE WAS OPEN MYOMECTOMY. WHAT IS THE CONDITION OF THE PATIENT? PATIENT HAS NO CO MORBIDITIES, FIT AND WELL. WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? YES. WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? YES. DOES A PIECE OF THE NEEDLE REMAIN IN THE PATIENT?S TISSUE? NO, WAS RETRIEVED UNDER THE X-RAY. WHAT TISSUE STRUCTURE IS IT LOCATED? SIZE OF THE NEEDLE PIECE RETAINED? FIRST LAYER OF THE UTERUS, NEEDLE WAS SPLIT INTO TWO. ARE ANY PLANS IN PLACE TO REMOVE THE NEEDLE PIECE IN FUTURE? HAS BEEN REMOVED. IF RETAINED, WHAT IS THE SURGEON'S OPINION OF CONSEQUENCES TO THE PATIENT? NOT RETAINED. WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE? A BIT OF DISSECTION DONE ON THE SECOND LAYER OF THE UTERUS. DEVICE RETURN - STAFF UNFORTUNATELY THROWN IN THE SHARPS BIN BUT TOO LATE TO PICK UP TO SEND TO COMPANY FOR ANALYSIS.?

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A MYOMECTOMY ON UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT ON FIRST LAYER OF THE UTERUS, THE NEEDLE BROKE, SPLIT INTO TWO. THE NEEDLE WAS RETRIEVED FROM THE PATIENT UNDER X-RAY. A BIT OF DISSECTION WAS DONE ON THE SECOND LAYER OF THE UTERUS. THE PATIENT HAS NO COMORBIDITIES, FIT AND WELL.