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

Catalog Number	1200011
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Scar Tissue (2060); Seroma (2069); Hernia (2240)
Date of Event	03/21/2017
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 mesh (device 1).An additional supplemental emdr was submitted to represent the ventrio st mesh (device 2).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) 2016 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of phasix st mesh (device 1).Per op notes, ¿a midline incision was made around the umbilicus and the old recurrent incisional hernia scar.The hernia sac was identified and excised.The old synthetic mesh was excised.A phasix st mesh (device 1) was placed into the peritoneal cavity and secured with sutures.¿ on (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with partial excision of phasix st mesh (device 1) and implant of ventrio st mesh (device 2).Per op notes, ¿an elliptical incision was made around the old incision scar.The hernia sac was identified with some serous fluid.It was suctioned free from the wound and dissected the capsule off the underlying scar tissue.A slight bulge in the scar from the absorbed hernia patch and some residual patch was noted which was excised.A ventrio st mesh (device 2) was placed in the peritoneum and tacked to the fascia with absorbable tackers and secured with sutures.¿ on (b)(6) 2017 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with implant of synthetic mesh.Per op notes, ¿an incision was made over the ventral hernia.The hernia sac was identified and omentum was dissected.The previously applied mesh was noted to be detached from the right side of the abdominal wall.Adjacent hernias were noted in the superior and inferior to the mesh.The hernia involved only the omentum.Adhesions between the omentum and the peritoneum were lysed.The defect was measured and the redundant sac was excised.Bilateral tap blocks were performed.A synthetic mesh was placed into the defect and tacked to the fascia with tacks and secured with sutures.¿.

• 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: 24504576
• Report Number: 1213643-2026-00277
• Device Sequence Number: 10440383
• Product Code: OWT
• UDI-Device Identifier: 00801741095283
• UDI-Public: (01)00801741095283(10)NI
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: 1200011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 66 KG