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

Catalog Number	1201325
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2016 ¿ patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with implant of perfix plug (device #1).Per operative notes, ¿an indirect hernia sac was identified and removed and medium perfix plug (device #1) was placed for the repair and secured with sutures.¿ (b)(6) 2017 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with implant of perfix plug (device #2).Per operative notes, ¿a large hernia in the direct space was identified.The previously placed dislodged synthetic mesh was noted and repaired with large perfix plug (device #2) and secured circumferentially with sutures.¿ (b)(6) 2017 ¿ patient was diagnosed with recurrent ventral hernia and right groin pain thereby underwent laparoscopic converted into open repair with implant of phasix st mesh (device #3).Per operative notes, ¿dense adhesions of hernia mesh (device #1 and #2) on both sides to bowel were removed.In left upper quadrant midline fascia in the was closed with sutures and phasix st mesh (device #3) was placed.(b)(6) 2019 ¿ patient was diagnosed with open abdominal wound thereby underwent open repair with excision of chronic abdominal wall sinus tract and removal of mesh (device #3).Per operative notes, ¿sinus tract in the epigastric abdominal with suture material and small pieces of mesh was found.The wound was irrigated and closed.¿.
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.Note, the manufacturing date (15-dec-2016) is considered to be a best estimate.This mdr represents the phasix st mesh (device #3).An additional supplemental emdr was submitted to represent the perfix plug (device #1), perfix plug (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.

• 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: 22724946
• Report Number: 1213643-2025-00728
• Device Sequence Number: 8418409
• Product Code: OWT
• UDI-Device Identifier: 00801741095306
• UDI-Public: (01)00801741095306(17)190228(10)HUAZ1877
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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: 02/28/2019
• Device Catalogue Number: 1201325
• Device Lot Number: HUAZ1877
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2016
• 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: 47 YR
• Patient Sex: Male