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

Catalog Number	1190500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, this was a patient who was aesthetically dissatisfied following weight loss, and not an alleged deficiency/malfunction of the device.This mdr is submitted to document the surgical intervention for mesh removal.To date, this is the only reported complaint for this manufacturing lot.This mdr represents the bard/davol phasix mesh (device #2).An additional mdr was submitted to represent the bard/davol phasix mesh (device #1).Device not returned - mesh explanted.
Event or Problem Description
As reported, the patient was implanted with two phasix mesh (device #1 and device #2) bilaterally on (b)(6) 2022.It was reported that post implant, the patient had lost weight voluntarily and aesthetically, was not happy and wanted to go back to permanent (silicone or saline) implants.As reported due to the patient¿s dissatisfaction, eight months post implant, the patient underwent surgical intervention for removal of the mesh on (b)(6) 2022.
Event or Problem Description
As reported, the patient was implanted with two phasix mesh (device #1 and device #2) bilaterally on (b)(6) 2022.It was reported that post implant, the patient had lost weight voluntarily and aesthetically, was not happy and wanted to go back to permanent (silicone or saline) implants.As reported due to the patient¿s dissatisfaction, eight months post implant, the patient underwent surgical intervention for removal of the mesh on (b)(6) 2022.
Additional Manufacturer Narrative
As reported, this was a patient who was aesthetically dissatisfied following weight loss, and not an alleged deficiency/malfunction of the device.This mdr is submitted to document the surgical intervention for mesh removal.To date, this is the only reported complaint for this manufacturing lot.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document a correction to the unique identifier (udi).Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 99 units released for distribution in november, 2021.Updated fields: b4, g3, g6, h2, h4 (device manufacture date), h6, h10, h11.Corrected field: d4 (unique identifier (udi)).This supplemental mdr represents the bard/davol phasix mesh (device #2).An additional mdr was previously submitted to represent the bard/davol phasix 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 - mesh explanted.

• 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: 15939066
• Report Number: 1213643-2022-00781
• Device Sequence Number: 6200691
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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: 07/28/2023
• Device Catalogue Number: 1190500
• Device Lot Number: HUFV1765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: 48 YR
• Patient Sex: Female