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

Catalog Number	1202025
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930); Seroma (2069)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported on (b)(6) 2023 the patient was implanted with phasix st mesh.Post implant the patient presented with cellulitis and was treated with antibiotics.About seven months post implant the patient presented to the ed with a seroma and was treated with antibiotics.As reported the seroma ¿cleared well¿ and the surgeon was ¿happy with how everything looked, and scans looked positive.¿ the patient ¿presented again with another case of seroma/cellulitis¿ and the surgeon decided to remove the mesh.On (b)(6) 2023 the patient underwent a revision procedure, and the mesh was explanted.As noted, ¿the lateral part of the mesh had integrated/absorbed so he wasn't concerned, however through the midline the mesh (approx.70 %) had not integrated at all, and this was where the mesh was infected.As reported, ¿the mesh was essentially floating between the muscle layers without any integration.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, the patient underwent mesh explant due to recurrent cellulitis/seroma, and subsequent mesh infection.The physical sample (explanted mesh) was discarded.Photos provided of the explanted mesh show the integrity of the mesh looks good and as expected at the duration of in-life.Photo review does not assist in determining root cause for the patient¿s postoperative course.Surgeon alleges poor integration of the mesh in the area of infection.Cellulitis, and seroma formation can diminish the potential for tissue integration.Seroma formation, and infection are known complications of surgery/use of the device and are listed in the adverse reactions section of the instructions-for-use, supplied with the device as possible complications.Regarding infection the warning 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 mesh." no lot number has been provided; therefore, a review of the manufacturing records is not possible.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 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: 17881160
• Report Number: 1213643-2023-00359
• Device Sequence Number: 15308135
• Product Code: OWT
• UDI-Device Identifier: 00801741095368
• UDI-Public: (01)00801741095368
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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 Catalogue Number: 1202025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/05/2023
• 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: Required Intervention
• Patient Sex: Unknown