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

Catalog Number	0118241
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	06/28/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 1 year 9 months post implant of dulex mesh, patient was diagnosed with hernia recurrence, adhesion, scar tissue thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list hernia recurrence and adhesion as a possible complication.This emdr represents the dulex mesh (device #1).An additional supplemental emdr was submitted to represent the ventraight st mesh (device #2).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.
Event or Problem Description
Per information provided: (b)(6)2010 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of dulex mesh (device #1).Per operative notes, ¿in the left lower quadrant, some dense adhesions to the sac were divided.There was an additional superior aspect hernia just to the right of midline was identified, adhesions were divided.A cutaneous bridge which had an old piece of mesh was divided, and a dulex mesh (device #1) was placed and sutured.¿ (b)(6)2012 - patient was diagnosed with recurrent right flank hernia thereby underwent open repair with the partial removal of dulex mesh (device #1) and implant of ventralight st mesh (device #2).Per operative notes, ¿after extensive lysis of adhesions, the hernia sac was dissected.The previous mesh (device #1) was resected and removed.A ventralight st mesh (device #2) was placed and sutured.¿ (b)(6)2015 - patient was diagnosed with multi-recurrent ventral incisional hernia thereby underwent open repair with the explant of dulex mesh (device #1) and implant of synthetic mesh.Per operative notes, ¿the hernia sac was found herniated into the sigmoid colon.The adhesions were lysed, and hernia contents were reduced.The fascia was densely scarred.There was a dulex mesh (device #1) below the previous ventralight st mesh (device #2) was removed.The ventralight st mesh (device #2) slightly divided, split and posterior rectus release was performed.Then, recreated the defect using sutures to secure the mesh back together and a synthetic mesh was secured to ventralight st mesh (device #2) with sutures.¿ attorney alleges that the patient had adhesions to small bowel, pain and hernia recurrence.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 1 year 9 months post implant of dulex mesh, patient was diagnosed with hernia recurrence, adhesion, scar tissue thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list hernia recurrence and adhesion as a possible complication.Addendum: h11: this supplemental emdr is submitted to correct the manufacturing site.Updated fields: b4, g3, g6, h2, h10, h11.Corrected field: g1 (manufacturing site).This emdr represents the mesh ¿ dulex (device #1).An additional supplemental emdr was submitted to represent the ventraight st mesh (device #2).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.
Event or Problem Description
Per information provided: on (b)(6) 2010 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of dulex mesh (device #1).Per operative notes, ¿in the left lower quadrant, some dense adhesions to the sac were divided.There was an additional superior aspect hernia just to the right of midline was identified, adhesions were divided.A cutaneous bridge which had an old piece of mesh was divided, and a dulex mesh (device #1) was placed and sutured.¿ (b)(6) 2012 - patient was diagnosed with recurrent right flank hernia thereby underwent open repair with the partial removal of dulex mesh (device #1) and implant of ventralight st mesh (device #2).Per operative notes, ¿after extensive lysis of adhesions, the hernia sac was dissected.The previous mesh (device #1) was resected and removed.A ventralight st mesh (device #2) was placed and sutured.¿ (b)(6) 2015 - patient was diagnosed with multi-recurrent ventral incisional hernia thereby underwent open repair with the explant of dulex mesh (device #1) and implant of synthetic mesh.Per operative notes, ¿the hernia sac was found herniated into the sigmoid colon.The adhesions were lysed, and hernia contents were reduced.The fascia was densely scarred.There was a dulex mesh (device #1) below the previous ventralight st mesh (device #2) was removed.The ventralight st mesh (device #2) slightly divided, split and posterior rectus release was performed.Then, recreated the defect using sutures to secure the mesh back together and a synthetic mesh was secured to ventralight st mesh (device #2) with sutures.¿ attorney alleges that the patient had adhesions to small bowel, pain and hernia recurrence.

• Brand Name: MESH ¿ DULEX
• 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): BRIDGER BIOMED, INC. -3031159; 2430 north 7th avenue; lot #1, road #3, km 79.7; bozeman MT 59715
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 21431423
• Report Number: 1213643-2025-090099
• Device Sequence Number: 4606586
• Product Code: FTL
• UDI-Device Identifier: 00801741011870
• UDI-Public: (01)00801741011870(17)150228(10)BRUB0042
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K003917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 02/28/2015
• Device Catalogue Number: 0118241
• Device Lot Number: BRUB0042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/18/2025
• 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: 42 YR
• Patient Sex: Female