MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG LIGHT; SURGICAL MESH

Catalog Number	0117180
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	11/21/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information provided: (b)(6) 2013 - patient was diagnosed with incisional wall hernia thereby underwent open repair with the implant of ventrio st (device #1) & perfix light plug (device #2).Per operative notes, ¿hernia sac was identified and reduced.For the upper supraumbilical hernia site, a ventrio st (device #1) was placed against the anterior abdominal wall.For the infraumbilical hernia site, a perfix light plug (device #2) was sutured in place.There was old ventral wall mesh which could be seen which was divided upon dissecting down to the fascia.¿ (b)(6) 2015 - patient was diagnosed with incarcerated recurrent ventral hernia thereby underwent open repair with explantation of meshes (device #1 & #2) from peritoneal cavity and repair of recurrent incarcerated ventral hernia with implant of ventrio st (device #3).Per operative notes, ¿two previous pieces of mesh were identified.The mesh appeared well incorporated into the anterior abdominal wall and had dense adhesions to underlying bowel were dissected off.Both pieces of mesh (device #1 & #2) were explanted and a ventrio st (device #3) mesh was placed into the anterior abdominal wall.¿ attorney alleges that the patient had adhesions, bowel obstruction, mesh migration, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 2 years 5 months post implant of perfix plug light, patient was diagnosed with hernia recurrence, obstruction and adhesions thereby underwent repair with mesh removal.The instructions-for-use supplied with device lists hernia recurrence and adhesions as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents perfix plug light (device #2).An additional supplemental emdr was submitted to represent ventrio 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: PERFIX PLUG LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 20627787
• Report Number: 1213643-2024-094807
• Device Sequence Number: 21037956
• Product Code: FTL
• UDI-Device Identifier: 00801741031014
• UDI-Public: (01)00801741031014(17)171228(10)HUWK1641
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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: 12/28/2017
• Device Catalogue Number: 0117180
• Device Lot Number: HUWK1641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2012
• 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: 36 YR
• Patient Sex: Female