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Catalog Number 0010302
Device Problems Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Hernia (2240)
Event Date 12/19/2017
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh. There are no medical records provided beyond this time, therefore the patient¿s clinical course is unclear. The explanted mesh was not returned to the manufacturer for evaluation. No pathology or diagnostic information was provided. Based on the information received, there is no way to determine whether the bard ventralex mesh may have caused or contributed to the problems experienced due to the patient¿s medical history, unknown surgical history and limited clinical information provided. A review of the manufacturing records was performed and found that the lot was manufactured to specification. The instructions-for-use (ifu) supplied with the device lists infection, hernia recurrence, adhesions and hematoma as possible complications. In regards to the infection, the warnings section of the instructions-for-use (ifu) states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the patch. An unresolved infection may require removal of the device. " should additional information be provided, a supplemental emdr will be submitted. Not returned.
Event Description
Per the legal claim: attorney alleges that on (b)(6) 2017, the patient was implanted with a bard/davol ventralex mesh. Attorney alleges that the patient is experiencing additional problems in the area, including considerable pain, discomfort and developed additional hernias. It was also alleged that the patient underwent a repair procedure on (b)(6) 2021 in which the surgeon described that the "surgical mesh had rolled up into a gumball indicating the failure of the mesh". It is also alleged that the device was defective. Per information provided in the patient's medical records: on (b)(6) 2017 - a (b)(6) year-old male patient was diagnosed with incisional hernia without obstruction or gangrene and underwent implant of a bard/davol ventralex mesh. On (b)(6) 2017 - the patient had noted increased swelling, pain, redness near the incision site and presented to the hospital. An exam and ct scan of the abd and pelvis was performed. The patient was admitted to the hospital with a wound and hematoma infection diagnosis and underwent a wound exploration procedure. Per the operative report detail, ¿patient has balancing erythema and warmth surrounding midline stapled incision. At the mid aspect, small area of skin separation with drainage. 3 staples from the mid aspect portion of the incision were removed. Using sterile instruments, a blunt clamp was used to probe the incision at the area where there was already some skin separation and immediately a moderate amount of malodorous old blood was expressed from the cavity. The cavity was probed digitally and with blunt clamp to break up loculations with expression of additional malodorous old blood. Then the cavity was irrigated with normal saline and packed with betadine soaked kerlix gauze. The patient tolerated the procedure well. ¿ on (b)(6) 2018 - the patient had a follow up office visit, and the wound was noted to be healing and was asked to continue the course of antibiotic treatment. On (b)(6) 2019 and (b)(6) 2019 - the patient was scheduled for tar (transversus abdominis release) surgery, which were cancelled. On (b)(6) 2021 - the patient underwent laparoscopic repair of recurrent incisional hernia located in left abdominal area in the prior hernia site, an adjacent hernia as well as an umbilical hernia. During the procedure, it was found that there extensive adhesions containing small bowel and omentum and also there was small bowel incarcerated within all three hernias. Per the operative report, ¿there were also extensive adhesions to this area containing small bowel and omentum. Most of the adhesions were around an old mesh (ventralex). Careful dissection was carried out to free the adhesions. The old mesh (which turned into a ¿gumball¿) was removed via the 12mm port site. The umbilical hernia (1cm in diameter) was closed with ethibond stitches. The span of all three hernias extended 12cm wide and 5cm in height. ¿ a non-bard/davol mesh (20 x 15cm parietex mesh) was then placed, and the incision site was closed. ".
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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 Key12428381
MDR Text Key270075991
Report Number1213643-2021-07418
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
Type of Report Initial
Report Date 09/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2020
Device Catalogue Number0010302
Device Lot NumberHUAZ0341
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2017
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: 09/06/2021 Patient Sequence Number: 1