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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX AB PORCINE SURGICAL MESH Back to Search Results
Catalog Number 1150610
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The returned sample has been evaluated and is confirmed for having a tear in the material. Visual examination confirms that the graft had been cut by the user as was reported. This cut presented an edge which allowed for the graft to tear while wet. There is a stretch spot present in the graft consistent with user manipulation at the top of the cut key hole on the same side the tear presented. Manipulation on this side of the cut key hole caused the graft to tear. Damage most likely presented when positioning the graft inside the body. No damage was noted prior to use. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Root cause is use related. 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.
 
Event Description
The following was reported to davol: it was reported that during a laparoscopic hiatal hernia repair the xenmatric ab tore in half. Reportedly, the graft was cut to allow a key hole and when placing to glue in, it tore while handling inside the belly. There was no injury to the patient. The graft was removed from the patient and returned to davol for evaluation.
 
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Brand NameXENMATRIX AB
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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5628266
MDR Text Key44394242
Report Number1213643-2016-00187
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2017
Device Catalogue Number1150610
Device Lot NumberHUZL0457
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received04/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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