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

Catalog Number	0112720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Seroma (2069)
Date of Event	04/18/2014
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 4).Additional supplemental emdrs were submitted to represent the kugel hernia patch (device 1), perfix plug (device 3).Note, the manufacturing date (15-dec-2013) is considered to be a best estimate.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 left inguinal hernia thereby underwent open repair with the implant of kugel hernia patch (device 1).(notes: no op notes were provided).(b)(6) 2014: patient was diagnosed with bilateral inguinal hernias and left flank abdominal wall hernia thereby underwent open repair for right inguinal hernia with the implant of perfix plug (device 2) and left inguinal hernia with perfix plug (device 3), bard flat mesh (device 4) and left flank or abdominal wall hernia with ventralex mesh (device 5).Per op notes, "an incision to the right inguinal ligament, a perfix plug (device 2) was placed using sutures.Attention to the left side, a perfix plug (device 3) and a bard flat mesh (device 4) were placed.Then an incision to the left flank or abdominal wall hernia, a ventralex mesh (device 5) was placed using sutures." (b)(6) 2014: patient was diagnosed with left groin hematoma, thereby underwent left groin wound exploration and evacuation of hematoma.Per op notes, "found a small sized seroma in the left inguinal region that was aspirated.Patient developed swelling and pain involving the left groin region.A hematoma was identified and was evacuated.".

• 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: 24951134
• Report Number: 1213643-2026-00547
• Device Sequence Number: 10105957
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(17)181228(10)HUXL0216
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 12/28/2018
• Device Catalogue Number: 0112720
• Device Lot Number: HUXL0216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2013
• 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: 60 YR
• Patient Sex: Female