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

Catalog Number	1202530
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Local Reaction (2035); Swelling/ Edema (4577)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, post implant of the phasix st mesh the patient experienced adverse reactions, including abdominal swelling, redness, and pain.Additionally, it is reported that approximately two years post implant of the phasix st mesh the mesh has not dissolved (resorbed).Per the instructions-for-use supplied with the device, ¿significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months, indicate loss in mechanical integrity and strength of the mesh.While fiber segments were observed at 18 months, they continued to degrade.¿ therefore, it is unclear if the mesh failed to resorb as reported or if the observed "mesh" at almost 2 years post implant was the still observable fiber segments remnants.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 37 units released for distribution in january 2020.Note, the date of event is estimated as 10-nov-2020, based on the information available.This emdr represents the phasix st mesh (device #2 ).An additional supplemental emdr (1213643-2019-08329) was submitted to represent the ventralight st mesh (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.H3 other text : not returned - remains implanted.
Event or Problem Description
As reported, the patient was implanted with a ventralight st mesh in 2018 and due to ¿severe fibrosis of the abdominal muscle¿ ¿chronic abdominal pain¿ and ¿inflammation¿ the patient underwent explant of the ventralight st mesh, on (b)(6) 2020.During this procedure, the patient was implanted with a phasix st mesh.It was reported the patient experienced ¿severe abdominal swelling, redness, heat, and pain¿ and visited the er on two occasions a month and half after the implant (phasix st mesh) was placed.As reported the patient has undergone ct scans and mir.As alleged, per radiology reports (not provided), ¿the mesh has not dissolved, the specialists are citing mesh rejection.¿ reportedly, the patient is under ongoing care with multiple specialists/doctors.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, post implant of the phasix st mesh the patient experienced adverse reactions, including abdominal swelling, redness, and pain.Additionally, it is reported that approximately two years post implant of the phasix st mesh the mesh has not dissolved (resorbed).Per the instructions-for-use supplied with the device, ¿significant degradation of the mesh fibers observed in preclinical studies within 12 to 18 months, indicate loss in mechanical integrity and strength of the mesh.While fiber segments were observed at 18 months, they continued to degrade.¿ therefore, it is unclear if the mesh failed to resorb as reported or if the observed "mesh" at almost 2 years post implant was the still observable fiber segments remnants.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 37 units released for distribution in (b)(6) 2020.Note, the date of event is estimated as (b)(6) 2020, based on the available information.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the dob of the patient.This supplemental mdr represents the phasix st mesh (device #2).An additional supplemental mdr was submitted to represent the ventralight st mesh (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.H3 other text : not returned - remains implanted.
Event or Problem Description
As reported, the patient was implanted with a ventralight st mesh in 2018 and due to ¿severe fibrosis of the abdominal muscle¿ ¿chronic abdominal pain¿ and ¿inflammation¿ the patient underwent explant of the ventralight st mesh, on (b)(6) 2020.During this procedure, the patient was implanted with a phasix st mesh.It was reported the patient experienced ¿severe abdominal swelling, redness, heat, and pain¿ and visited the er on two occasions a month and half after the implant (phasix st mesh) was placed.As reported the patient has undergone ct scans and mir.As alleged, per radiology reports (not provided), ¿the mesh has not dissolved, the specialists are citing mesh rejection.¿ reportedly, the patient is under ongoing care with multiple specialists/doctors.

• 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: 15587176
• Report Number: 1213643-2022-00646
• Device Sequence Number: 2810222
• Product Code: OWT
• UDI-Device Identifier: 00801741095375
• UDI-Public: (01)00801741095375
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 12/28/2021
• Device Catalogue Number: 1202530
• Device Lot Number: HUDT1817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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: 44 YR
• Patient Sex: Female