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

Catalog Number UNKAA107

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

As reported by a surgeon who was performing a medical record review, post-implant of the onflex mesh the patient experienced bleeding/hematoma.As treatment the implanting surgeon explanted the mesh and soaked it in saline and then re-implanted the mesh into the patient.It was reported that following the reimplantation the patient developed a postoperative infection and the contacting surgeon reports that the subsequent infection does not appear to have been device related.The medical records were not provided and the information is limited to what the reporting surgeon was willing to provide.Postoperative hematoma is a known inherent risk of surgery and is listed in the adverse reaction section of the instructions-for-use (ifu) as a possible complication.Additionally, the warnings section of the ifu states "this device is for single use only.Do not resterilize or reuse any portion of the onflex mesh." though the reporting surgeon reported the patient¿s post-operative infection did not appear to be device related, and infection is a known risk of surgery, in regards to infection, the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.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, the date of event is provided as a best estimate based on the date of awareness.Should additional information be provided, a supplemental mdr will be submitted.Remains implanted.

Event Description

As reported by a surgeon who was performing a medical record review, during an open inguinal repair procedure a bard/davol onflex mesh was implanted into the patient.It was reported that during recovery, the patient started bleeding and developed a hematoma.Reportedly, the implanting surgeon removed the mesh, soaked it in saline and re-implanted the mesh.Following the subsequent procedure, the patient developed a postoperative infection.

• Brand Name: ONFLEX
• Type of Device: 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: 11872597
• MDR Text Key: 252331964
• Report Number: 1213643-2021-20127
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention