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

Catalog Number	1193045
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the subject patient developed acute abdominal pain following a complex procedure during which a phasix mesh had been implanted.As reported the "pancreatic leak is the primary cause of the acute abdominal pain in this patient, the contributory role of the study device to the event is possible." the clinician has assessed the patient¿s postoperative outcome of acute abdominal pain as possibly related to the study device.However, based on the information provided, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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
As reported per the clinical trial (b)(4): on (b)(6) 2025, the subject patient underwent an open exploratory laparotomy with distal pancreatectomy, splenectomy splenic artery lymphadenectomy, omental flap, liver wedge biopsy as concomitant procedures, during which the patient was implanted with phasix mesh using 3-0 pds absorbable monofilament suture.The midline fascia was completely closed with slow absorbing monofilament 0 pds sutures using running stitch.Subject patient had a pancreatic leak from pod 3 drain amylase and was sent home on (b)(6) 2025 with jps to remove later.On (b)(6) 2025, the patient was diagnosed with abdominal pain.The patient was admitted to the hospital on (b)(6) 2025 with fever and underwent ct imaging.It was noted the luq drain site had redness & purulent drainage.On (b)(6) 2025, the patient underwent a ct scan showing soft tissue stranding throughout the right flank encompassing the left drain, which may reflect developing cellulitis.Redness had grown on subject's side.The subject patient's pain was managed with po and iv medication.As reported, "although the pancreatic leak is the primary cause of the acute abdominal pain in this patient, the contributory role of the study device to the event is possible based available information." as reported, the adverse event (acute abdominal pain) has been assessed per clinician (medical monitor) as possibly related to the study device with a causal relationship to the procedure and recovering/resolving.The ae has been assessed as moderate in severity.The reported ae does meet the definition of a sae (serious adverse event) and does not meet the definition of usade (unanticipated serious adverse device event).
Event or Problem Description
As reported per the clinical trial (b)(4): on (b)(6) 2025 the subject patient underwent an open exploratory laparotomy with distal pancreatectomy, splenectomy splenic artery lymphadenectomy, omental flap, liver wedge biopsy as concomitant procedures, during which the patient was implanted with phasix mesh using 3-0 pds absorbable monofilament suture.The midline fascia was completely closed with slow absorbing monofilament 0 pds sutures using running stitch.Subject patient had a pancreatic leak from pod 3 drain amylase and was sent home on (b)(6) 2025 with jps to remove later.On (b)(6) 2025 the patient was diagnosed with abdominal pain.The patient was admitted to the hospital on (b)(6) 2025 with fever and underwent ct imaging.It was noted the luq drain site had redness & purulent drainage.On (b)(6) 2025 the patient underwent a ct scan showing soft tissue stranding throughout the right flank encompassing the left drain, which may reflect developing cellulitis.Redness had grown on subject's side.The subject patient's pain was managed with po and iv medication.As reported, "although the pancreatic leak is the primary cause of the acute abdominal pain in this patient, the contributory role of the study device to the event is possible based available information." as reported, the adverse event (acute abdominal pain) has been assessed per clinician (medical monitor) as possibly related to the study device with a causal relationship to the procedure and recovering/resolving.The ae has been assessed as moderate in severity.The reported ae does meet the definition of a sae (serious adverse event) and does not meet the definition of usade (unanticipated serious adverse device event).Addendum: as reported, the adverse event (acute abdominal pain) has been assessed per clinician (medical monitor) as not related to the study device with a causal relationship to the procedure and recovered/resolved.The ae has been assessed as moderate in severity.The reported ae does meet the definition of a sae (serious adverse event) and does not the definition of usade (unanticipated serious adverse device event).
Additional Manufacturer Narrative
As reported, the subject patient developed acute abdominal pain following a complex procedure during which a phasix mesh had been implanted.As reported the "pancreatic leak is the primary cause of the acute abdominal pain in this patient, the contributory role of the study device to the event is possible." the clinician has assessed the patient¿s postoperative outcome of acute abdominal pain as possibly related to the study device.However, based on the information provided, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the initial mdr submitted to document that the ae was clinically re-evaluated as not related to the study device.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 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: 21850261
• Report Number: 1213643-2025-00326
• Device Sequence Number: 8101935
• Product Code: OOD
• UDI-Device Identifier: 00801741107672
• UDI-Public: (01)00801741107672(11)230628(17)250528(10)HUHT1764
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: 05/28/2025
• Device Catalogue Number: 1193045
• Device Lot Number: HUHT1764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 118 KG