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

Catalog Number	0117080
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Foreign Body Reaction (1868); Thrombocytopenia (4431)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient experienced chronic rheumatic inflammation (all joints), granulomatous inflammation and a significant drop in platelet count post implant of perfix light plug.Based on the information provided, no conclusions can be made as to the degree to which the implant may have caused or contributed to the postoperative complication.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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
As reported per ansm report ((b)(4)): as reported, on (b)(6) 2025 the patent underwent strangulated inguinal hernia repair with the implant of perfix light plug.Date of occurrence: (b)(6) 2025.Description of the incident: chronic rheumatic inflammation (all joints).Date: (b)(6) 2025: clinical history: the patient was seen in the er for incarcerated right inguinal hernia and underwent reduction with monitoring and referral for hernia repair in scheduled surgery.Supine position, general anesthesia, orotracheal intubation.Procedure: right inguinal incision via direct approach after infiltration with naropain 7.5.Crossing of the various musculo-aponeurotic planes.A crural hernia was indeed found with a hernial sac containing omental fat, which was resected.Insertion of a large plug (perfix light plug) into the crural orifice, secured with cardinal sutures.Closure layer by layer.Skin staples pathological anatomy and cytology unit excerpt from the examination report on the sample taken on (b)(6) 2025.Clinical information: treatment of strangulated inguinal hernia with prosthesis.Inguinal lymphadenopathy fixed in pet scan.Investigation for hematological disease or inflammatory granuloma on foreign bodies.Report: a fragment measuring 2 x 1.5 x 1 cm, appearing more fibrous than ganglionic.The entire sample was included.Microscopically, it is fibrous tissue containing a fairly abundant lymphocytic inflammatory infiltrate and numerous foreign particles refracting polarized light, surrounded by macrophages and multinucleated giant cells.These particles vary in shape, most often rectangular or oval, and are highly refractive.The morphological characteristics are consistent with polyethylene debris.Conclusion: resorptive granulomatous inflammation on prosthetic particles with a morphology consistent with polyethylene debris.No evidence of malignancy.Current patient status: currently hospitalized due to a significant drop in platelet count (down to 1,000 at its lowest).

• Brand Name: PERFIX PLUG LIGHT
• 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: 24700315
• Report Number: 1213643-2026-00384
• Device Sequence Number: 15996524
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970(17)290128(10)HUJP0508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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 Catalogue Number: 0117080
• Device Lot Number: HUJP0508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2024
• 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: Female