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Catalog Number 5950040
Device Problem Defective Device (2588)
Patient Problems Abdominal Pain (1685); Hernia (2240); Disability (2371)
Event Date 12/18/2018
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made. There are no medical records provided beyond this time, therefore the patient¿s clinical course is unclear. No pathology information was included. Based on the information received, there is no way to determine whether the bard ventralex st and/or ventrio st mesh may have caused or contributed to the problems experienced due to the patient¿s unknown medical and surgical history and the limited clinical information provided. The instructions-for-use supplied with the ventrio st lists recurrence of the hernia as a possible complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. This emdr represents the bard/davol ventrio st (device #2). An additional emdr was submitted to represent the bard/davol ventralex st (device #1). Should additional information be provided, a supplemental emdr will be submitted.
Event Description
Per the legal claim: attorney alleges that on (b)(6) 2017, the patient was implanted with a bard/davol ventralex st mesh and a bard/davol ventrio st mesh on (b)(6) 2018. It is alleged that as a result of implantation of mesh products, the patient suffered personal injuries, was required and will continue to require treatment, has suffered and will continue to suffer pain mental anguish, and disability. It is also alleged that the device was defective. Per patient medical records: (b)(6) 2017 - a male patient diagnosed with recurrent incisional hernia of abdominal wall with gangrene was scheduled for repair. The patient¿s left upper quadrant was entered using a 5 mm trocar; a 2nd trocar was also placed. A recurrent hernia was noted in the area of the previous umbilical hernia repair; there was incarcerated omentum and intra-abdominal fat, which was reduced and cleared using a non-bard/davol (ligasure) device. The bowel was not incarcerated. The old (unspecified) mesh and wadded up and was scarred into the new sac. A counter-incision was then made reopening the previous infra-umbilical incision. This was carried down to the old mesh which was then excised in its entirety. Per the operative report details, ¿an 8 cm ventral patch (bard ventralex st) was selected and soaked in antibiotic irrigation. This patch was then placed intra-abdominal and pulled flush the anterior abdominal wall. It was secured circumferentially to the myofascial tissue using multiple interrupted 0-ethibond sutures. ¿ (b)(6) 2017 - ct-abdomen & pelvis showed recurrent incisional hernia (5 cm) with internal stranding suggestive of inflammation, with no gangrene, obstruction, pain or evidence of infection. (b)(6) 2017 - about 1-month later, the patient had a follow-up visit during which the patient had felt a ¿tearing¿ in the post-op period and presented with a new bulge. The patient requested for narcotics. The surgeon recommended the patient to quit smoking, to lose weight and informed the hernia has to be surgically repaired again. The patient wanted to have the surgery later. (b)(6) 2018 - the patient was admitted on (b)(6) 2018 for recurrent incisional repair, scheduled the next day. (b)(6) 2018 - per the operative report: ¿the patient¿s prior incision was opened directly over the hernia sac. The hernia sac was dissected free down to the level of the myofascial defect. The sac was then opened and was found to contain incarcerated small bowel. This was densely adhered to the hernia sac. The bowel was inflamed and friable. It is carefully dissected free of the hernia sac and was noted to have approximately 4 cm long serosal injury. ¿ given the friable nature of the bowel and the serosal injury, a section of the small bowel was then resected, and the hernia sac was removed. The fascial defect was noted to be 4x3 cm. ¿the old mesh had torn through the lateral fascia of the right side of the patient¿s abdomen. The defect was then cleaned back to healthy myofascial tissue circumferentially. A 15x11 ventral (bard/davol ventrio st) mesh was then selected and soaked in antibiotic solution. The mesh was secured to the myofascial edges using 0 ethibond sutures with excellent overlap in 360°. ¿ upon completion, there was no tension on the repair and no residual hernia noted. The incarcerated hernia sac and small bowel specimens were set to pathology.
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Manufacturer (Section D)
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
MDR Report Key11092728
MDR Text Key225489284
Report Number1213643-2020-11484
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2019
Device Catalogue Number5950040
Device Lot NumberHUBX1073
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2017
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: 12/29/2020 Patient Sequence Number: 1