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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955680
Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Migration (4003); Material Split, Cut or Torn (4008)
Patient Problems Fistula (1862); Strangulation (2084); Hernia (2240); Bowel Perforation (2668)
Event Date 12/15/2019
Event Type  Injury  
Event Description
Attorney alleges that on (b)(6) 2019, the patient had a pre-operative diagnoses of an incisional hernia. In the course of the surgery, it was found that the patient had extensive abdominal adhesions and the hernia was repaired laparoscopically with a bard/davol of ventralight st mesh with echo ps. Attorney alleges that approximately two months after the operation implanting the ventralight st mesh with echo ps, the patient began suffering post-surgical complications of pain and concern that possible mesh migration or failure had occurred. It is alleged that the patient continued to have problems and was finally seen by a surgeon, who on (b)(6) 2020, approved surgical repair for the painful hernia implant failure. Attorney alleges that at that time, an abdominal binder (hernia mesh) no longer helped as the patient's intestines protruded through the holes of the detached mesh, strangling them and causing bowel obstruction and ulcerative colitis which was extremely painful and extremely dangerous. It is alleged that after the (b)(6) 2020 approval for surgical repair, and for the past year, on dozens of occasions, the patient requested that the approved hernia repair surgery be performed but all attempts to obtain such surgery were denied or ignored by the defendants, patient's healthcare provider and the doc. It is alleged that during this period with regard to the mesh problem, the patient suffered continuous pain, and had to continually attempt to physically push the protruding hernia back into the abdominal cavity. Attorney alleges that patient's hernia mesh caused side effects from the procedure in that the mesh failed, totally migrated, developed holes in the mesh and generally caused incredible pain, ulcerative colitis and other medical conditions as a result of the mesh itself. Attorney alleges that the complications included erosions, adhesion, recurring hernias, perforations, mesh shrinkage and chronic pain. It is also alleged that once the mesh began to erode, it shrinks, shrivels and pulls away from any tissue its adhered to leading to new hernias, chronic pain and migration together with adhesions, bowel obstruction and fistula. These side effects were incurred by patient. Attorney alleges past and future pain and suffering, for medical complications as a result of the failure of its defective product.
 
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 bowel strangulation, perforation, hernia recurrence, obstruction, fistula, erosion and adhesion. The instructions-for-use (ifu) supplied with the device lists hernia recurrence, fistula and adhesions as possible complications. No lot number has been provided; therefore, a review of the manufacturing records is not possible. Note, as specific event date was not provided, the date of event was estimated as (b)(6) 2019. Should additional information be provided, a supplemental emdr will be submitted.
 
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Brand NameVENTRALIGHT ST W/ ECHO
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 Key12849870
MDR Text Key281073703
Report Number1213643-2021-08811
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial
Report Date 11/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5955680
Was Device Available for Evaluation? No
Date Manufacturer Received11/10/2021
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: 11/21/2021 Patient Sequence Number: 1
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