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	Ecchymosis (1818)
Date of Event	01/21/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, about one week post-implant of the ventralight st mesh, the patient was diagnosed with ecchymosis, resolved with no treatment required.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and definitely related to the index procedure, however, based on the information provided, no conclusion can be made.This mdr represents the ae of ecchymosis.Additional mdrs were submitted to represent aes of seroma and adhesions.Device not returned - remains implanted.
Event or Problem Description
Reported per clinical trial dvl-he-020: (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) 2013 subject patient was diagnosed with significant ecchymosis in the lower abdomen.No treatment given.Noted improvement on the 2nd follow up visit; no ecchymosis was noted on the 3rd follow-up visit.Per the study clinician, the reported adverse event has been assessed as mild in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as 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: 14464997
• Report Number: 1213643-2022-00275
• Device Sequence Number: 4515443
• 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): 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 60 KG