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

Catalog Number	1190400
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	04/30/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Addendum per additional information provided: on (b)(6) 2015 - patient was diagnosed with supraumbilical abdominal hernia thereby underwent open repair with the implant of ventralex st (device #1).Per operative notes, ¿the hernia sac containing preperitoneal fat due to obesity was excised.The umbilicus had a small hernia that was connected to other hernia above umbilicus, making this a ventral hernia repair.A ventralex st was then placed as an underlay patch under the fascia with some omentum behind the mesh and sutured through the marlex side of the mesh.¿ on (b)(6) 2016 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with removal of ventralex st (device #1) and implant of phasix mesh (device #2).Per operative notes, ¿lysis of some adhesions off the old mesh (device #1) was performed and excised the mesh completely.The hernia defect was identified and did a component separation.A phasix mesh (device #2) was then trimmed, placed in the retrorectus space and sutured.¿ on (b)(6) 2016 - patient underwent incision and drainage of abdominal wall abscess.Per operative notes, ¿some sutures were removed in the subcutaneous and the abscess pocket was entered.The wound was copiously irrigated.The abdominal wall was intact and no mesh was palpated.¿ attorney alleges that the patient had abscess, adhesions, bowel obstruction, hernia recurrence, infection and emotional injuries.It is also alleged that the patient underwent additional surgery to remove the mesh and repair the hernia and to treat for infection.Also had permanent and severe scarring and disfigurement.
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 3 weeks post implant of phasix mesh, patient underwent drainage of abdominal wall abscess.This emdr represents the phasix mesh (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.

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 20201984
• Report Number: 1213643-2024-094677
• Device Sequence Number: 15349298
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692(17)171128(10)HUZK0865
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: 11/28/2017
• Device Catalogue Number: 1190400
• Device Lot Number: HUZK0865
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 112 KG