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

Catalog Number	1191025
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hematoma (1884)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided no conclusion can be made.The information provided is limited.Multiple attempts have been made requesting additional information.Hematoma formation and wound dehiscence are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification should additional information be provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient was implanted with a bard/davol phasix mesh.Postoperatively the patient developed a hematoma and wound dehiscence.The surgeon requested a surgeon to surgeon consult, which was granted and negative pressure wound therapy (npwt) was recommended to treat the patient.

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8564891
• Report Number: 1213643-2019-03503
• Device Sequence Number: 2232574
• Product Code: OOD
• UDI-Device Identifier: 00801741107580
• UDI-Public: (01)00801741107580
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 05/28/2019
• Device Catalogue Number: 1191025
• Device Lot Number: HUBS0193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention