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

Catalog Number	5954790
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	09/04/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, about 2.5 years post implant of the bard/davol ventralight st mesh, the patient diagnosed with severe bowel intraabdominal adhesions during a surgical procedure and underwent take-down of adhesions.As reported, ae is reported as resolved.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and possibly related to the index procedure, however, based on the information provided, no conclusion can be made.Adhesion is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists adhesions as a possible complication.This mdr represents the ae of adhesion.Additional mdrs were submitted to represent aes of seroma and ecchymosis.Not returned - remains implanted.
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2013 - subject patient underwent a primary open midline infra umbilical hernia repair procedure, during which a bard/davol ventralight st mesh was implanted using mechanical fixation and sutures.Full skin closure was achieved using staples.The subject patient was discharged from the hospital on (b)(6) 2013.(b)(6) 2015 - subject patient underwent a laparoscopic surgery for presumed hydrosalpinx, but upon inspection, there was no hydrosalpinx or cyst found, severe intraabdominal adhesions were found, which were taken down.The patient was discharged the same day.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.

• Brand Name: VENTRALIGHT ST MESH
• 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: 14464954
• Report Number: 1213643-2022-00268
• Device Sequence Number: 20005107
• Product Code: FTL
• UDI-Device Identifier: 00801741031663
• UDI-Public: (01)00801741031663
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2022

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 Expiration Date: 06/28/2014
• Device Catalogue Number: 5954790
• Device Lot Number: HUWF1130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/21/2022
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 60 KG