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

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.

• Brand Name: 3DMAX LIGHT
• Type of Device: SURGICAL 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 Key: 12476581
• MDR Text Key: 271550541
• Report Number: 1213643-2021-20328
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• 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 Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0117321
• Device Lot Number: HUEU1796
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2020
• 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