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

Catalog Number	1191020
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Sepsis (2067); Bowel Perforation (2668); Insufficient Information (4580)
Date of Event	02/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh) on (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh (bard flat mesh).Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient sustained personal injury, experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this is an addendum to the initial emdr submitted (mdr number 1213643-2023-090061).This supplemental emdr is being submitted to report the additional information provided regarding the implanted device.Should additional information be provided, a supplemental emdr will be submitted.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
Attorney alleges that the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh) on (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh (bard flat mesh).Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient sustained personal injury, experienced emotional distress and the device was defective.Addendum: it was reported that the patient had multiple issues and surgeries since implant of bard flat mesh back in 2019.It was reported in jan-2020 "patient begin to get bloated' then become septic in feb-2020.It was also reported that the mesh had gotten into the intestine, deteriorated and had huge scar on the stomach after another surgery.It was reported that the patient had been taking pain killers.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh) on (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh (bard flat mesh).Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient sustained personal injury, experienced emotional distress and the device was defective.Addendum as per additional information provided: as reported, patient had multiple issues and surgeries after the implant of phasix mesh in late 2019.After two days, patient became sick and developed infection.Patient began to get bloated and was told by doctors that mesh was fine on (b)(6) 2020.On (b)(6) 2020, patient became septic, the mesh had gotten into intestines and deteriorated part of the intestines and now had a huge scar on stomach after another surgery.It was reported that the patient quality of life diminished and almost got addicted to pain killers due to the amount of pain.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum #1: this supplemental emdr is being submitted to report the additional information provided regarding the implanted device.Addendum #2: h11: this supplemental emdr is submitted to correct the event and product information that was incorrectly documented in previous supplemental emdr.Based on the information provided, no conclusions can be made as to what if any extent the phasix mesh caused or contributed to the patient¿s post operative condition.The instructions-for-use (ifu) supplied with the device identifies infection, pain in the adverse reactions section as a possible post-op complications.In regards to infection the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require the removal of the mesh." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is considered to be a best estimate as 15-feb-2020 based on the information available.Updated fields: b3 (date of event).Corrected fields: d1 (brand name), d.2 b, d4 (catalog no.& udi no.), g4 (pma/510(k) #).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.H3 other text: not returned.

• 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: 16120153
• Report Number: 1213643-2023-090061
• Device Sequence Number: 15316932
• Product Code: OOD
• UDI-Device Identifier: 00801741107573
• UDI-Public: (01)00801741107573
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024
• 2 Devices were Involved in the Event: 1 2

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: 1191020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 07/01/2024; 07/17/2024
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 07/17/2024; 07/23/2024
• 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: Life Threatening; Required Intervention
• Patient Sex: Female