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

Catalog Number	0112660
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hematoma (1884); Obstruction/Occlusion (2422)
Date of Event	02/27/2012
Type of Reportable Event	Serious Injury
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 flat mesh (device 2).An additional supplemental emdr was submitted to represent the composix kugel mesh (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.
Event or Problem Description
Per information provided: (b)(6) 2009 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of composix kugel mesh (device 1).Per op notes, ¿prior incision was re-opened.A large left lower quadrant hernia defect containing the omentum was identified and reduced.A composix kugel mesh (device 1) was placed within the fascial defect and secured with sutures.¿ (b)(6) 2010 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with partial excision of composix kugel mesh (device 1).Per op notes, ¿a palpable bulge was noted in the left lower quadrant.A large amount of mesh begins to extrude through the hernia defect into the anterior abdominal wall.The mesh was not fixed to the abdominal wall, extruding through the fascia and eroding the abdominal wall.The mesh (device 1) was excised, and the remaining mesh was well incorporated.The defect was closed primarily with sutures.¿ (b)(6) 2012 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with excision of composix kugel mesh (device 1) and implant of bard flat mesh (device 2).Per op notes, ¿a vertical midline incision was made.A moderate sized hernia defect was identified at the lower aspect of the incision.The mesh (device 1) was noted to be floating free and not adherent to the fascia.The mesh (device 1) was fully mobilized and excised.The fascial laxity was also noted in the left lateral area and several weakness were noted which were repaired with sutures.A bard flat mesh (device 2) was placed and secured with sutures." (b)(6) 2012 - patient was diagnosed with small bowel obstruction thereby underwent repair.Per op notes, ¿a vertical midline incision was made towards the previous midline scar.The mesh (device 2) was not fully approximated the fascia with a small amount of old hematoma present.Adhesions to the midline fascia was lysed and the bowel was taken down.The bowel was freed up from all adhesions.The proximal jejunum appeared scarred and redundant.The defect was closed and repaired with sutures.The mesh (device 2) was not incorporated and the fascia was trimmed to incorporate the area and repaired with sutures.¿ (b)(6) 2013 ¿ the patient was diagnosed with small bowel obstruction thereby underwent open repair with lysis of adhesions.A vertical midline incision was made.Dense adhesions were identified and dissected free.The old mesh (device 2) was well incorporated.The bowel was adherent to the fascia and was dissected free.The wound was mobilized off the anterior abdominal wall and adhesions were lysed.A ring type area of obstruction was identified and the area was lysed.The serosal tears were repaired with sutures.".

• Brand Name: BARD FLAT 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: 24504680
• Report Number: 1213643-2026-00278
• Device Sequence Number: 10509890
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(17)160928(10)HUVI0527
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: 09/28/2016
• Device Catalogue Number: 0112660
• Device Lot Number: HUVI0527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2011
• 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: 46 YR
• Patient Sex: Female