XENMATRIX AB UNKAA105

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-02-10 for XENMATRIX AB UNKAA105 manufactured by .

Event Text Entries

[67156186] As requested the surgeon was provided with a doctor to doctor consult. Based on information obtained following the consult it appears that the patient was experiencing an exaggerated foreign body response, it also appears that the graft was not placed flat which could contribute to the reported incorporation of the graft. The precaution section of the ifu states, place device in maximum possible contact with health, well vascularized tissue to promote cell ingrowth and tissue remodeling. Inflammation and allergic reaction or hypersensitivity to device materials are listed in the adverse reaction section of the ifu as possible complications. Multiple attempts have been made to obtain the product code and lot number of the xenmatrix ab graft, however the user was not willing to provide this information. Without a lot number a review of the manufacturing records is not possible. Based on the information provided, no definitive conclusion can be made as to why the graft did not incorporate. Should additional details be provided, 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.
Patient Sequence No: 1, Text Type: N, H10


[67156187] It was reported that on (b)(6) 2016 the patient underwent a breast reconstruction procedure in which the surgeon used the xenmatrix ab in the abdomen as an overlay graft on the rectus sheath to reinforce a tram/diep. The surgeon now reports the graft has increased in thickness since implant and has not incorporated. Surgeon also reports inflammation and the patient is complaining of severe pain. A portion of the graft was sent for culture with results showing no infection. The surgeon contacted davol and requested a surgeon consult regarding this case.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213643-2017-00096
MDR Report Key6322584
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-02-10
Date of Report2017-02-10
Date Mfgr Received2017-01-16
Date Added to Maude2017-02-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAURA BERG
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone4018258462
Manufacturer G1BARD SHANNON LIMITED -3005636544
Manufacturer StreetSAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7
Manufacturer CityHUMACAO PR 00791
Manufacturer CountryUS
Manufacturer Postal Code00791
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXENMATRIX AB
Generic NamePORCINE SURGICAL MESH
Product CodePIJ
Date Received2017-02-10
Model NumberNA
Catalog NumberUNKAA105
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-02-10

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