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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD SOFT MESH SURGICAL MESH Back to Search Results
Model Number N
Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Swelling (2091); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative

No conclusion can be made. Based on the information provided we are unable to determine a correlation between the patient's reported postoperative symptoms and the davol mesh product used to treat the patient. A mesh sample has been provided to the patient's allergist for reactivity testing. At this time, the testing has not been completed. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be obtained, a supplemental emdr 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.

 
Event Description

As reported on (b)(6) 2018 the patient underwent the repair of bilateral inguinal hernias. The hernias were repaired with bard/davol soft mesh (lot # hubx1610). It is reported that shortly afterwards, the patient developed irritation and local pain with intermittent swelling at the surgical sites. He also has developed over recent months multiple symptoms including increased fatigue, weight loss, and ¿allergies¿ to some foods including raw apples and potatoes and to multiple medications. At this time the allergist is not certain what is causing these symptoms and would like to obtain a sample of the mesh to rule this out.

 
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Brand NameBARD SOFT MESH
Type of DeviceSURGICAL 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 Key7854933
MDR Text Key119505728
Report Number1213643-2018-03047
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN
Device Catalogue Number0117015
Device LOT NumberHUBX1610
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 Received10/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/13/2017
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: 09/07/2018 Patient Sequence Number: 1
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