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

Catalog Number	1230008
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Chest Pain (1776); Hypersensitivity/Allergic reaction (1907)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient was implanted with a phasix st umbilical hernia patch on (b)(6) 2025.It was reported that the patient feels like they are having an allergic reaction with multiple symptoms including hives, shortness of breath, chest pain, abdominal pain, body aches.As reported the patient has consulted with an allergy specialist and her physician regarding her symptoms and has visited multiple hospitals and has been hospitalized.
Additional Manufacturer Narrative
As reported, the patient feels like they are having an allergic reaction post implant of a phasix st umbilical hernia patch.As reported the patient has multiple known allergies/sensitivities including to the permanent sutures used in surgery.A ct scan showed, "no findings to directly account for the patient's reported symptoms.Postsurgical change of anterior hernia repair are noted with mesh placement.The mesh appears present and uncomplicated in appearance." based on the information available to date, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complication.Allergic reaction is listed in the adverse reactions section of the instructions-for-use supplied with the device as a possible complication.A review of the manufacturing records was performed and found the lot was manufactured to the specification.To date, this is the only reported complaint for this manufacturing lot of 308 units released for distribution.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: PHASIX ST UMBILICAL HERNIA PATCH
• 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: 23361323
• Report Number: 1213643-2025-01007
• Device Sequence Number: 18383763
• Product Code: OWT
• UDI-Device Identifier: 00801741226571
• UDI-Public: (01)00801741226571(11)240314(17)251228(10)HUJQ1549
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K243241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2025

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: 12/28/2025
• Device Catalogue Number: 1230008
• Device Lot Number: HUJQ1549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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: Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female