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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number 0112680
Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Diarrhea (1811); Dysuria (2684); Constipation (3274); Unspecified Gastrointestinal Problem (4491)
Event Date 10/20/2016
Event Type  Injury  
Manufacturer Narrative
Based on the information provided a cause of the alleged postoperative complications cannot be determined. A review of the manufacturing records was performed and found that the lot was manufactured to specification. The review found no indication of a manufacturing related cause for the patient's alleged postoperative complications. Remains implanted.
 
Event Description
It was reported that on (b)(6) 2004 the patient was implanted with a bard flat mesh for the repair of a right sided inguinal hernia. As reported the patient is experiencing irritable bowel syndrome, diverticulitis, colonitis, leukocytosis, 2 lung nodules, several cysts, constant pain, hiatal hernia, weight fluctuations with severe weight loss due to off and on bouts of bloating and then diarrhea.
 
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Brand NameBARD FLAT 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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key8432132
MDR Text Key139189127
Report Number1213643-2019-01759
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2009
Device Catalogue Number0112680
Device Lot Number43DOD034
Was Device Available for Evaluation? No
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2004
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: 03/19/2019 Patient Sequence Number: 1
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