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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX PORCINE SURGICAL MESH Back to Search Results
Catalog Number UNKAA081
Device Problem Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
The information presented in the article is without patient/case specific details. Additional information has been requested from the article contact. To date there has been no response. At this time, based on the information provide no conclusion can be made. Seroma formation is a known inherent risk of surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication. A lot number was not provided; without a lot number a review of the manufacturing records is not possible. Should additional information be provided, a supplemental emdr will be submitted. This record documents the 7 patients with seroma. Two additional emdrs have been submitted to represent the reported recurrence and abdominal pain. Not returned.
 
Event Description
Per journal article surgery dec. 2016, "biologic mesh in ventral hernia repair: outcomes, recurrence, and charge analysis". In summary alloderm, allomax, flex hd, strattice and xenmatrix were used in open ventral hernia repair. The article stated that 22 patients that were implanted with xenmatrix experienced 59. 1% recurrence. Identifies other post-op complications including; seroma 31. 8%, abdominal pain 55. 0%. Information is presented without patient/case specific details.
 
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Brand NameXENMATRIX
Type of DevicePORCINE SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key8824183
MDR Text Key152177818
Report Number1213643-2019-06343
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 literature,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA081
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/24/2019 Patient Sequence Number: 1
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