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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 ONFLEX SURGICAL MESH Back to Search Results
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.

 
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Brand NameONFLEX
Type of DeviceSURGICAL 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 Key11872597
MDR Text Key252331964
Report Number1213643-2021-20127
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142711
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
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 Received05/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA107
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
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 TREATMENT DATA
Date Received: 05/24/2021 Patient Sequence Number: 1
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