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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
Catalog Number 0117016
Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120)
Event Type  Injury  
Event Description
Attorney alleges that on or about (b)(6) 2019, the patient underwent laparoscopic surgical repair of a bilateral inguinal hernia with bilateral ilioinguinal nerve block. During surgery, the patient was implanted with either a non-bard/davol (parietene) mesh device and/or bard soft mesh device. It is alleged that after the surgery, the patient experienced emergence agitation post-anesthesia; shortly after the surgery and the implantation of the non-bard/davol mesh device and/or bard soft mesh device, the patient developed severe urinary tract infection that required antibiotics and pain killers. It is alleged that after the surgery, the patient began to experience severe pain, discomfort, and injuries, including but not limited to low back, abdomen, leg, pelvic, groin and testicular pain, cramping, inflammation, infection, swollen and discolored testicles, frequent/inability to urinate, nerve and tissue damage, abnormal growth/masses, groin bulge, nausea, dizziness, insomnia, and fatigue. Attorney alleges that since the surgery and being implanted with the non-bard/davol mesh device and/or bard mesh device, the patient's symptoms have become severe and intolerable, and the patient experiences ongoing pain and suffering. It is alleged that despite the severity of the symptoms, surgical removal of the mesh is too dangerous for the patient due to the negative reaction to anesthesia and is not recommended. It is further alleged that the patient continues to experience severe and debilitating pain and discomfort on a daily basis and as the direct result of the defendants¿ actions/omissions, the patient suffered injuries and disabilities that has resulted in immense pain and suffering. It is alleged that the patient has undergone and will be required to undergo in the future extensive hospital, medical, surgical, pharmacological, therapeutic, and other treatments. It is also alleged the device was defective.
 
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including disability, chronic pain, nerve damage and infection. The instructions-for-use (ifu) supplied with the device lists infection and inflammation as possible complications. No lot number has been provided; therefore, a review of the manufacturing records is not possible. In regard to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. " should additional information be provided, a supplemental emdr will be submitted.
 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key12832360
MDR Text Key281012128
Report Number1213643-2021-08747
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K052155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0117016
Was Device Available for Evaluation? No
Date Manufacturer Received11/03/2021
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: 11/17/2021 Patient Sequence Number: 1
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