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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117321
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Purulent Discharge (1812); Pain (1994); Post Operative Wound Infection (2446)
Event Date 06/18/2021
Event Type  Injury  
Manufacturer Narrative
As reported, the patient experienced complications postoperatively and underwent surgical intervention for mesh removal 11 days post-implant of the 3dmax light mesh. Based on the information provided, no conclusion can be made. Postoperative infection is a known inherent risk of surgery. In regard to infection, the warnings section of the instruction for use (ifu) states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in december, 2020. Should additional information be provided, a supplemental mdr will be submitted. Not returned - mesh explanted.
 
Event Description
Per nmpa ((b)(6)fda): on (b)(6) 2021 - the patient underwent laparoscopic tension-free repair of the right inguinal hernia with bard/davol 3dmax light mesh under general anesthesia. During the surgery, the right indirect inguinal hernia was confirmed and the entire operation went smoothly and the postoperative recovery was smooth. On (b)(6) 2021 - the patient was discharged. When discharged from the hospital, the patient felt a little pain in the operation area, without abdominal pain, bloating, and fever. On (b)(6) 2021 (after 7 days) - the patient returned to outpatient clinic with complaints of mild swelling in the right groin area, slight pain, no fever and the suture was removed at that time. On (b)(6) 2021 - the patient had fever and increased pain in the right inguinal area. Ct examination of the abdomen showed that the right inguinal canal was dilated with effusion and was accompanied by spotty dense shadows. The patient was hospitalized and underwent fluid aspiration. Approximately 50ml of pale-blooded fluid was drawn out and the patient was treated with anti-infection treatment. On (b)(6) 2021 - under the guidance of b-ultrasound, the right groin area was punctured and 300ml of purulent fluid drained under local anesthesia. Anti-infection treatment was strengthened. Pus culture showed no bacterial growth. On (b)(6) 2021 - a re-examination of abdominal ct showed right lower abdominal effusion with spot-like dense shadows, the lesion extended and was enlarged and the surrounding exudation had increased. On (b)(6) 2021 - the patient underwent laparoscopic removal of the bard/davol 3dmax light mesh under general anesthesia. Anti-inflammatory treatment was provided and the patient recovered.
 
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Brand Name3DMAX LIGHT
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
8005566756
MDR Report Key12476581
MDR Text Key271550541
Report Number1213643-2021-20328
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other,use
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0117321
Device Lot NumberHUEU1796
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2020
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: 09/15/2021 Patient Sequence Number: 1
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