MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX ST MESH; SURGICAL MESH

Catalog Number	1200710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Urticaria (2278)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed hives post implant of phasix st mesh.Photos provided show a red rash/reaction on the patient's abdomen, back and leg.As reported the patient has a doxycycline allergy (hives).Per the instructions-for-use (ifu), supplied with the device ¿mesh manufacture involves exposure to tetracycline hydrochloride and kanamycin sulfate.The safety and product use for patients with hypersensitivities to these antibiotics is unknown.Use of this mesh in patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided.¿ the patient is currently being evaluated by her doctors to determine what may have caused this reaction.Based on the information provided at this time, no definitive conclusions can be made.Allergic reaction is listed in the adverse reactions section of the ifu, identifies allergic reaction as a possible complication.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 117 units.Note, the date of event is considered to be a best estimate as (13-feb-2025) based on the date of awareness.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 the patient underwent a paraesophageal hernia repair on (b)(6) 2025 with the implant of a phasix st mesh.Post implant the patient is experiencing full body hives.Patient is currently undergoing a dermatology and allergy work up.

• Brand Name: PHASIX ST MESH
• 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: 21547846
• Report Number: 1213643-2025-00082
• Device Sequence Number: 15217476
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337(11)240723(17)270628(10)HUJU1357
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2025

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 Catalogue Number: 1200710
• Device Lot Number: HUJU1357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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 Age: 60 YR
• Patient Sex: Female