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

Catalog Number	1190200
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ischemia (1942); Necrosis (1971); Pain (1994)
Date of Event	10/06/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about few days post implant of phasix mesh, patient was diagnosed with necrosis, ischemia and pain.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-jun-2014) is considered to be a best estimate.This emdr represents the phasix mesh (device #2).Additional supplemental emdr was submitted to represent the perfix plug (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) 2014 - patient was diagnosed with direct left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, ¿an indirect sac was seen and cord lipoma was dissected free.The large direct defect was noted.The large perfix plug (device #1) was placed into the defect, secured with interrupted sutures.The onlay patch was then placed into the canal, secured in all directions with the interrupted sutures.¿ (b)(6) 2015 - patient was diagnosed with left ilioinguinal nerve entrapment thereby underwent repair with partial removal of mesh (device #1).Per operative notes, ¿the edges of the mesh were dissected out laterally and superiorly.Ilioinguinal nerve into the area and some other fibrous bands were divided.¿ (b)(6) 2015 - patient was diagnosed with chronic left groin pain thereby underwent repair.Per operative notes, ¿flap was created superiorly and then inferiorly freed up the cord and mesh (device #1) through considerable scar tissue to the inferior edge of the mesh.The mesh (device #1) was intact.The tails of previously placed mesh had separated and there was a small defect lateral to the internal ring was reapproximated with sutures.¿ (b)(6) 2015 - patient was diagnosed with infected mesh thereby underwent open repair with the removal of perfix plug (device #1).Per operative notes, ¿there was a large cavity in the subcutaneous tissues overlying the fascia that had purulent debris within it.There were severe inflammatory changes.The overlay portion of the mesh from inferior attachments were mobilized and excised the polypropylene overlay.The plug in the direct space was very minimally incorporated in the preperitoneal space and was dissected from dense medial attachments along the cooper ligament, and the fascial insertions on the pelvis.The plug was completely excised.¿ (b)(6) 2015 - patient underwent open repair for washout of left groin and reconstruction of inguinal canal using phasix flat mesh (device #2).Per operative notes, ¿phasix long-term bio-reabsorbable mesh (device #2) was placed as overlay to reconstruct the floor of inguinal canal and then used sutures to approximate the mesh in an interrupted fashion to cooper ligament and the medial attachments at the pelvis and then along the inferior aspect, anchored the mesh to the iliopubic tract.Superiorly, tacked the mesh to the internal oblique muscle and fascia.¿ (b)(6) 2015 - patient was diagnosed with ischemia, pain and necrosis thereby underwent scrotal orchiectomy.Per operative notes, ¿the ischemic necrosis testicle was dissected from surrounding tissues was found to be grossly edematous.There was a presence of necrosis of the cord as well.¿ attorney alleges that the patient had adhesions, abscess, loss of testicle, mesh migration, pain, ring break, infection and emotional injuries.

• Brand Name: PHASIX MESH
• 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: 21419209
• Report Number: 1213643-2025-090090
• Device Sequence Number: 15421666
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678(17)170328(10)HUYFTP13
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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: 03/28/2017
• Device Catalogue Number: 1190200
• Device Lot Number: HUYFTP13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2014
• 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: 69 YR
• Patient Sex: Male