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

Catalog Number	0117016
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Scar Tissue (2060)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2014 - patient was diagnosed with multiple incisional/ventral hernias thereby underwent laparoscopic repair with implant of ventralight st (device 1).Per op notes, ¿epigastric and umbilical hernia sacs were noted with small other multiple hernia defects.All the defects were reduced and dissected free.Both the defects were joined.A ventralight st mesh (device 1) was placed and secured using sutures.¿ (b)(6) 2014 - patient was diagnosed with small bowel obstruction and adhesions thereby underwent laparoscopic converted to open repair with lysis of adhesions.Per op notes, ¿multiple dilated loops of small bowel and the prior mesh (device 1) adherent to the anterior abdominal wall was taken down.Some serous fluid was suctioned out.Adhesions were lysed.Dilated and collapsed bowel was released.¿ (b)(6) 2015 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of bard soft mesh (device 2).Per op notes, ¿scar tissue was excised.Lysis of adhesions were performed.Enterotomy was made, the bowel was transected.Injured bowel was transected.The prior mesh (device 1) was noted.The hernia was repaired using bard soft mesh (device 2) was placed and sutured.¿ (b)(6) 2020 - patient was diagnosed with enterocutaneous fistula and frozen abdomen thereby underwent open repair.Per op notes, ¿upper midline incision was made and scar was incised.The prior meshes (device 1 and 2) were noted.Adhesions were lysed.The surgery was aborted due to frozen abdomen.The wound vac was placed and sutured.¿.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This mdr represents the bard soft mesh (device #2).An additional supplemental emdr was submitted to represent the ventralight st (device #1).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.

• Brand Name: BARD SOFT 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: 24504789
• Report Number: 1213643-2026-00281
• Device Sequence Number: 15938466
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932(17)200328(10)HUZC1625
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: 03/28/2020
• Device Catalogue Number: 0117016
• Device Lot Number: HUZC1625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2015
• 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: 53 YR
• Patient Sex: Male