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

Catalog Number	0117160
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol perfix light plug (device # 2).An additional emdr was submitted to represent the bard/davol 3dmax mesh (device # 1), bard/davol 3dmax mesh (device # 3) and bard/davol 3dmax mesh (device # 4).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/ davol 3dmax mesh (3x) and perfix light plug on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol 3dmax mesh (3x) and perfix light plug on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2014 - patient was diagnosed with left inguinal hernia thereby underwent robotic-assisted laparoscopic repair with the implant of 3dmax mesh (device #1).Per operative notes, ¿noted a large left inguinal hernia containing a loop of small intestine.A large 3dmax left-sided mesh was inserted.The patch was then positioned over the dissected inguinal structures, covering the indirect defect and direct and femoral potential spaces.Securestrap tacker was obtained, and the mesh was tacked medially to cooper ligament and then laterally to transversalis fascia.A small hiatal hernia was visualized.¿ (b)(6) 2014 - patient was diagnosed with recurrent left inguinal hernia thereby underwent robotic-assisted laparoscopic repair with the implant of perfix plug light (device #2) & two 3dmax meshes (device #3 & #4).Per operative notes, ¿the sigmoid colon was noted to be adherent to the peritoneum in the left lower quadrant, and a portion of this protruded into a left inguinal hernia.Dissected the left preperitoneal space and noted the previously placed mesh prosthesis had shifted medially and cephalad, allowing for recurrence of an indirect hernia.A medium perfix plug light (device #2) was inserted into the abdomen and placed into the internal ring.This was sutured in place medially and laterally to the fascia forming the internal ring.A left-sided large 3dmax mesh (device #3) was inserted.Then positioned the mesh in the dissected right preperitoneal space and was tacked with a securestrap tacker.A left-sided medium 3dmax mesh (device #4) was inserted similarly and tacked to cooper¿s ligament and the transversalis fascia.¿ attorney alleges that the patient had adhesions, hernia recurrence, mesh migration, pain & suffering.It was also alleged that the patient underwent recurrent left inguinal hernia; sigmoid colon adherent to the peritoneum in the left lower quadrant; mesh migration - previously placed mesh had shifted medially and cephalad.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Upon review of medical records, it was confirmed there was no adverse event or medical/surgical intervention associated to the perfix plug light that implanted on (b)(6) 2014 to treat the patient's left inguinal hernia.This supplemental emdr represents the perfix plug light (device #2).Additional supplemental emdr's were submitted to represent the 3dmax mesh (device #1, device #3 & device #4).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: 9557701
• Report Number: 1213643-2020-00114
• Device Sequence Number: 2334659
• Product Code: FTL
• UDI-Device Identifier: 00801741030994
• UDI-Public: (01)00801741030994(17)190528(10)HUXJ0088
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• 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,Followup
• Report Date (Section B): 09/23/2024

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: 05/28/2019
• Device Catalogue Number: 0117160
• Device Lot Number: HUXJ0088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 09/23/2024
• 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 Sex: Male