MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5992025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article: "laparoscopic intraperitoneal mesh repair of a large incisional hernia in a kidney transplantation patient: a case report".The article reports a case regarding a large incisional hernia in a 73-year-old kidney transplant patient being successfully treated by minimally invasive laparoscopic ipom repair.The article notes that the kidney transplant was performed when the patient was 40 years old and has been maintained on immunosuppressive therapy with prednisone and tacrolimus.Fifteen years post-transplant, the patient was diagnosed with an incisional hernia in the lateral aspect of the transplant incision that had gradually and painfully increased in size.The complex hernia repair (at age 73) was completed using a bd/bard ventralight st with echo 2 mesh, fixated using a bd/bard capsure straight fixation device.As reported ¿postoperatively, a subcutaneous seroma developed in the dead space of the incised hernia and resolved 10 weeks later without intervention.Although the bulging was mildly admitted, the abdominal wall almost returned to its original state, and the patient's body contour improved.One year after the operation, the patient has not experienced any obvious recurrence.¿ this file represents ventralight st w/echo 2.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made. the information is limited to the journal article.Seroma is a known inherent risk of surgery/use of the device and included as possible complication in the adverse reactions section of the instructions-for-use (ifu) supplied with the device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event ((b)(6) 2020) is provided as an estimate based on the available information.This mdr represents the ventralight st w/ echo 2.An additional mdr was submitted to represent the capsure straight.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• Common Device Name: 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: 16987259
• Report Number: 1213643-2023-00207
• Device Sequence Number: 6762568
• Product Code: FTL
• UDI-Device Identifier: 00801741131042
• UDI-Public: (01)00801741131042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5992025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female