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

Catalog Number	1201015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Drug Resistant Bacterial Infection (4553)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This mdr represents the phasix st (device 2).An additional supplemental emdr was submitted to represent the ventralex 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: on (b)(6) 2018 - patient was diagnosed with umbilical hernia thereby underwent open repair with implant of ventralex st (device 1).Per op notes, ¿the hernia sac was identified and dissected free.The hernia sac was excised.A ventralex st (device 1) was placed and sutured circumferentially.¿ on (b)(6) 2018 - patient was diagnosed with abdominal wall abscess, seroma and hematoma thereby underwent open repair.Per op notes, ¿the incision was opened.A cavity above the prior mesh was noted.It contained seroma and old hematoma were evacuated.¿ on (b)(6) 2018 - patient was diagnosed with recurrent incarcerated incisional hernia with infected mesh, abscess and abdominal pain thereby underwent open repair with excision of ventralex st (device 1) and implant of phasix st (device 2).Per op notes, ¿abscess was encountered and drained.The prior mesh (device 1) was noted.The omentum adherent to mesh was excised.The infected omentum excised.All the abscess cavity was drained.The infected prior mesh (device 1) was excised completely.The hernia defect was noted and reduced.A phasix st (device 2) was placed and sutured.¿ on (b)(6) 2018 - patient was diagnosed with chronically infected mrsa wound infection involving mesh thereby underwent open repair with excision of phasix st (device 2) and implant of biological mesh.Per op notes, ¿a large amount of purulent fluid associated with mesh (device 2) was drained.The total infected wound was excised.Adhesions were lysed.The infected mesh (device 2) was excised completely.Flaps were raised bilaterally.A biological mesh was placed and sutured.¿.

• 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: 24505050
• Report Number: 1213643-2026-00285
• Device Sequence Number: 9943022
• Product Code: OWT
• UDI-Device Identifier: 00801741095344
• UDI-Public: (01)00801741095344(17)200228(10)HUCN0728
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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 Expiration Date: 02/28/2020
• Device Catalogue Number: 1201015
• Device Lot Number: HUCN0728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2018
• 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: 41 YR
• Patient Sex: Male