FDA.reportPublic FDA data

MAUDE MDR 6305675

MDR report key
6305675
Report number
1213643-2017-00077
Event key
0
Event type
3
Date of event
2016-12-08
Date received
2017-02-06
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
LAURA BERG
Address
100 CROSSINGS BLVD. WARWICK RI 02886 US
Phone
401-401-4018
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1XENMATRIX ABPORCINE SURGICAL MESHDAVOL INC., SUB. C.R. BARD, INC.PIJNA1152025HUZL0467R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-0601. O

Event Narratives#

N

Patient 1

BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT POST OPERATIVE DIARRHEA. A PROBIOTIC REGIMEN WAS RECOMMENDED AS TREATMENT AND THE PATIENT CONDITION IS REPORTED TO BE RESOLVING. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. SHOULD ADDITIONAL INFORMATION BE REPORTED REGARDING THE PATIENT'S CONDITION, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. REMAINS IMPLANTED.

D

Patient 1

THE FOLLOWING WAS REPORTED AND IS ASSOCIATED WITH THE PHASIX STUDY DVL-HE-012. ON (B)(6) 2016 - THE PATIENT WAS IMPLANTED WITH A BARD XENMATRIX AB GRAFT. ON (B)(6) 2016 - THE PATIENT PRESENTED FOR FOLLOW UP VISIT. THE PATIENT REPORTS POST OPERATIVE DIARRHEA OCCURRING ROUGHLY 2-3 DAYS /WEEK. A PROBIOTIC REGIMEN WAS RECOMMENDED (AT LEAST 1OZ OF KEFIR/YOGURT FOR NEXT 2 MONTHS). OUTCOME IS REPORTED AS "RESOLVING" AND THE PATIENT STATES THAT SHE IS GETTING BETTER. THIS EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE DEVICE.