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	Abscess (1690); Cellulitis (1768); Inflammation (1932); Sepsis (2067)
Date of Event	08/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 2 years 1 month post implant of phasix mesh, patient was diagnosed with sepsis, cellulitis, abscess, inflammation.The instructions-for-use supplied with the device list inflammation as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-apr-2015) is considered to be a best estimate.This emdr represents the phasix mesh (device #2).Additional supplemental emdr was submitted to represent the ventrio st (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 by patient¿s attorney: (b)(6) 2015 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of ventrio st mesh (device #1).Per operative notes, ¿the hernia sac was excised.A ventrio st mesh (device #1) was placed into the abdomen and sutured.¿ (b)(6) 2015 - patient was diagnosed with ventral incisional hernia and exploratory laparotomy thereby underwent open repair with the explant of old mesh (device #1) and implant of phasix mesh (device #2).Per operative notes, ¿the fascia was closed under the seroma, grasped the ventrio st mesh (device #1) and were able to pull away from the anterior abdominal wall.The seroma was entirely drained, and the mesh was removed.Adhesions were taken down.A phasix mesh (device #2) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with abscess & sepsis, open wound abdominal wall thereby underwent excision & debridement of skin and subcutaneous tissue to fascia.Per operative notes, ¿incising the skin and subcutaneous tissue overlying the open draining wound and area of cellulitis.All chronically inflamed tissue was removed.¿ attorney alleges that the patient had adhesions, pain, infection, hernia recurrence and seroma.It was also alleged that the patient had excision and debridement of nonviable and chronically inflamed tissue and washout of abdominal wound.

• 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: 21879726
• Report Number: 1213643-2025-090164
• Device Sequence Number: 20990458
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678(17)170428(10)HUZD0741
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/22/2025

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: 04/28/2017
• Device Catalogue Number: 1190200
• Device Lot Number: HUZD0741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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: Life Threatening; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female