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

Catalog Number	1201520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fistula (1862)
Date of Event	11/20/2017
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.Note, the manufacturing date (15-jun-2017) is considered to be a best estimate.This emdr 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 additional information provided: (b)(6) 2014 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of ventralex st (device #1).Per operative notes, ¿the hernia sac was identified and excised.A ventralex st (device #1) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with recurrent ventral incisional & umbilical hernia with abdominal pain thereby underwent open repair with implant of phasix st (device #2).Per operative notes, ¿dense adhesions of small bowel to abdominal wall were taken.The small bowel was stuck in the mesh were released.The hernia sacs were identified and reduced.A phasix st (device #2) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with gastrointestinal fistula & wound dehiscence thereby underwent open repair with excision of mesh (device #1 & #2).Per operative notes, ¿the previous mesh (device 1# & #2) was identified with free floating sutures were removed completely.The area of fistula identified and repaired with sutures.Wound vac was placed.¿ (b)(6) 2018 - patient was diagnosed with incisional hernia and fistula thereby underwent open repair with implant of biological mesh and fistula repair.(b)(6) 2018 - patient was diagnosed with abdominal wound thereby underwent open repair with placement of wound vac.

• 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: 22193783
• Report Number: 1213643-2025-00471
• Device Sequence Number: 15780706
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351(17)190728(10)HUBT1491
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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: 07/28/2019
• Device Catalogue Number: 1201520
• Device Lot Number: HUBT1491
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2017
• 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: 56 YR
• Patient Sex: Female