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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX PORCINE SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX PORCINE SURGICAL MESH Back to Search Results
Catalog Number 1161520
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907)
Event Date 01/06/2022
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, no conclusion can be made. As reported, one month post implant of the xenmatrix graft, the patient presented with a pus pocket behind the graft and underwent explant. There were no signs of infection and as reported, the surgeon suspects the patient had a reaction to the graft. Allergic reaction is identified as a potential complication in the adverse reaction section of the instructions-for-use, supplied with the device. Review of manufacturing records confirms product was manufactured to specification. To date, this is the only complaint reported for this manufacturing lot (b)(4) released for distribution in april, 2021. Note, the date of explant is estimated as on (b)(6) 2022, based on the information available.
 
Event Description
As reported, during a colostomy reversal procedure on (b)(6) 2021, a bard/davol xenmatrix graft (porcine) was implanted in the patient. It was reported that one month post implant, on (b)(6) 2022, the patient presented with a pus pocket behind the graft. As reported, the pocket was cultured, it was sterile pus and the graft was explanted. As reported, the surgeon indicated that the patient did not have any infection since the culture was negative. As reported, the surgeon felt that the patient had some type of reaction to the xenmatrix graft (porcine).
 
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Brand NameXENMATRIX
Type of DevicePORCINE SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
8005566756
MDR Report Key14025846
MDR Text Key288704213
Report Number1213643-2022-00137
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140501
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1161520
Device Lot NumberHUFQ0280
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2022 Patient Sequence Number: 1
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