MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 PerFix Plug; Surgical Mesh

Catalog Number	0112950
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol perfix plug (device #1) used to treat the patient.No lot number has been provided therefore a review of the manufacturing records is not possible.This emdr represents the bard/davol perfix plug (device #1).The patient's attorney did not make any allegations regarding the implanted bard/davol ventralex st device.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2012, the patient underwent surgery for implant of an unspecified bard/davol perfix plug (device #1) and an unspecified bard/davol ventralex st.As reported, the patient is only making a claim for an adverse patient outcome against the perfix plug (device #1).As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".
Event or Problem Description
Attorney alleges that on (b)(6) 2012, the patient underwent surgery for implant of an unspecified bard/davol perfix plug (device #1) and an unspecified bard/davol ventralex st.As reported, the patient is only making a claim for an adverse patient outcome against the perfix plug (device #1).As reported, the attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." addendum per additional information provided: (b)(6) 2012- patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of perfix plug (device 1).Per op notes, ¿a transverse inguinal skin incision was made and carried down to the external oblique aponeurosis.The external oblique was incised from the external inguinal ring.The hernia sac was dissected from the cord structures, opened, ligated and amputated.A perfix plug was placed into the residual fascial defect and fixed in place and was secured with sutures.The inguinal floor was reinforced with a mesh patch and was secured with pubic tubercle, the conjoint tendon and the shelving edge of the poupart¿s ligament.¿ (b)(6) 2017- patient was diagnosed with recurrent right inguinal hernia and umbilical hernia, mesh protrusion, adhesion thereby underwent laparoscopic repair with implant of ventralex st mesh (device 2) and synthetic mesh and partial explant of perfix plug (device 1).Per op notes, ¿a transverse incision was made superior to the umbilicus and dissected down to the fascia.The previously placed perfix plug (device 1) and patch were found to be protruding into the peritoneum and right groin.The peritoneum overlying the inguinal region was incised.Dissection was carried down below the cooper¿s ligament and iliopubic tract.The small section of peritoneum that was densely adherent to the previous mesh was left intact.Some portion of densely adhered mesh was excised.A small cord lipoma in the indirect space was identified and reduced.A synthetic mesh was placed into the inguinal floor and was secured with sutures.A ventralex st mesh (device 2) was placed into the umbilical hernia defect.The fascia was then closed transversely over the mesh and secured with sutures.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol perfix plug (device #1) used to treat the patient.No lot number has been provided therefore a review of the manufacturing records is not possible.This emdr represents the bard/davol perfix plug (device 1).The patient's attorney did not make any allegations regarding the implanted bard/davol ventralex st device.Addendum: this supplemental emdr is submitted to document additional information provided.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.Note, the manufacturing date (15-sep-2011) is considered to be a best estimate.Updated fields: a2, b2, b3, b4, b5, b7, d3, d4 (product catalog no, corporate lot no, udi no., expiry date), d6b, g1, g3, g6, h2, h4, h6, h10.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: PerFix Plug
• 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 ; +1(401)825-8495
• MDR Report Key: 8750327
• Report Number: 1213643-2019-05680
• Device Sequence Number: 13992025
• Product Code: FTL
• UDI-Device Identifier: 00801741016653
• UDI-Public: (01)00801741016653(17)161028(10)HUVI2049
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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: 10/28/2016
• Device Catalogue Number: 0112950
• Device Lot Number: HUVI2049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Disability; Required Intervention
• Patient Sex: Male