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

Catalog Number	1190500
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed an infection thereby underwent revision surgery post implant of phasix mesh.Contact information was not provided.Based on the information available, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient¿s clinical course.Infection is known inherent risks of surgery/use of the device.The adverse reaction section of the instructions-for-use, supplied with the device identifies infection as a possible complication.The warnings section 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 removal of the device".Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 95 units released for distribution in march 2023.This emdr represents the phasix mesh.An additional emdr was submitted to represent the arista ah.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 per medwatch form (mw5155891): "hernia mesh implant resulting in infection revision surgery and prolonged infection.Cr bardmesh hrna repair 25cmx31cm implant type: mesh/peg, implanted area: abdomen laterality: n/a, implanted on (b)(6) 2023.Number implanted: 1 status: implanted, manufacturer cr bard, model number: 1190500, lot number: hugz0902, serial number: sealnt pwdr hemos 3gm arista implant type sealant implanted area: abdomen laterality: n/a implanted on (b)(6) 2023.Number implanted: 2 medical center revision surgery (b) (6) after mri and bloodwork showed abdominal infection.Hospitalized third time (b)(6) with recurring infection.Blood work and antibiotics for three days." this file represents the phasix mesh.

• 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: 19760965
• Report Number: 1213643-2024-00365
• Device Sequence Number: 8624877
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708(17)241128(10)HUGZ0902
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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: 11/28/2024
• Device Catalogue Number: 1190500
• Device Lot Number: HUGZ0902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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 Age: 43 YR
• Patient Sex: Male
• Patient Weight: 94 KG