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

Catalog Number	1201010
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	05/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported 4 weeks post-op the patient had a stroke, and per the surgeon it is possible this caused the erosion into the esophagus as the sutures did not hold.However, based on the information provided no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's post operative course.The adverse reactions section of the instructions-for-use supplied with the device states, "possible complications in hiatal hernia repair may include esophageal erosion.¿ a review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august 2023.Note, the date of event is considered to be a best estimate as 03-may-2024 based on the information provided.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, during a hiatal hernia repair with fundoplication on (b)(6) 2024 the patient was implanted with phasix st mesh.As reported the surgeon ¿thinks it¿s possible the patient may have an erosion due to the fact that the patient had a stroke 4-weeks post-op.¿ as reported the sutures didn¿t hold, and he believes ¿part of the suture and mesh may have eroded into the esophagus.¿ per the surgeon, no additional surgery is going to be performed at this time.The patient is stable and will be discharged.

• 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: 19609128
• Report Number: 1213643-2024-00331
• Device Sequence Number: 6520423
• Product Code: OWT
• UDI-Device Identifier: 00801741095320
• UDI-Public: (01)00801741095320
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: 11/28/2025
• Device Catalogue Number: 1201010
• Device Lot Number: HUHU0533
• 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: 06/10/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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: Required Intervention
• Patient Sex: Female