FDA.reportPublic FDA data

MAUDE MDR 9864835

MDR report key
9864835
Report number
1213643-2020-02800
Event key
0
Event type
3
Date of event
2020-03-09
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LAURA SUNDBERG
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
1PHASIX ST W/ OPSSURGICAL MESHDAVOL INC., SUB. C.R. BARD, INC.OWTNA1220011HUDR0705R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. R

Event Narratives#

N

Patient 1

AS REPORTED EARLY POSTOPERATIVE ADHESIONS OCCURRED. THE SAMPLE WAS NOT PROVIDED FOR EVALUATION. PHOTOS WERE PROVIDED SHOWING BOTH SIDES OF THE MESH POST EXPLANT, AND ALSO A PHOTO OF THE DISTENDED BOWEL AND DILATED BOWEL. REVIEW OF THE PHOTOS DID NOT ASSIST IN DETERMINING A ROOT CAUSE FOR THE POSTOPERATIVE ADHESIONS AND OBSTRUCTION. AS REPORTED THE MESH WAS NOT HYDRATED PRIOR TO IMPLANT AS PRESCRIBED IN THE INSTRUCTIONS-FOR-USE, IT IS UNCLEAR IF THIS MAY HAVE CONTRIBUTED TO THE POSTOPERATIVE ADHESIONS AND OBSTRUCTION. BASED ON THE INFORMATION PROVIDED AND PHOTO EVALUATION, NO CONCLUSION CAN BE MADE. THE INSTRUCTIONS-FOR-USE STATES, "HYDRATION OF THE DEVICE FOR 1-3 SECONDS IS RECOMMENDED. " AND "DEVIATION FROM RECOMMENDED INSTRUCTIONS AND/OR PROCEDURAL STEPS WITHIN THIS IFU MAY RESULT IN DISRUPTION OR DELAMINATION OF THE HYDROGEL BARRIER OF THE MESH. HYDROGEL DISRUPTION OR DELAMINATION MAY CAUSE AN UNEXPECTED INCREASE IN ADHESION FORMATION IN THE AREA WHERE IT IS DISRUPTED." ADHESION FORMATION IS A KNOWN INHERENT RISK OF SURGERY AND IS LISTED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. TO DATE THIS IS THE ONLY REPORTED COMPLAINT FOR THIS PRODUCTION LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN JULY, 2019. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. NOT RETURNED.

D

Patient 1

IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT WAS IMPLANTED INTRA-ABDOMINALLY WITH A BARD PHASIX ST MESH (OPS) DURING AN OPEN UMBILICAL HERNIA REPAIR PROCEDURE. AS REPORTED THE MESH WAS NOT HYDRATED PRIOR TO IMPLANT. THE SEPRA (ST) BARRIER WAS PROPERLY ORIENTED TOWARD THE BOWEL WITH THE MESH SIDE TOWARD THE ABDOMINAL WALL. ON (B)(6) 2020 DUE TO AN OBSTRUCTION THE PATIENT WAS BOUGHT BACK TO THE OR AND UNDERWENT EXPLANT OF THE MESH. DENSE ADHESIONS TO THE MESH WERE REPORTED. THE DOCTOR NOTED THAT IN A PHOTO TAKEN OF THE BOWEL YOU CAN "CLEARLY SEE WHERE THE DISTENDED BOWEL AND DILATED BOWEL ARE THAT CAUSED THE OBSTRUCTION AND IN THE CENTER YOU CAN SEE THE LEFT BEHIND SEPRAFILM FROM THE MESH."