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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number 0112680
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Swelling (2091); Fluid Discharge (2686)
Event Date 08/18/2020
Event Type  Injury  
Manufacturer Narrative
As reported, it is alleged the next day after implant of the bard flat mesh, the patient experienced redness, swelling and fluid leakage around the incision area. Wound care was provided and the incision healed well. Based on the information provided to date, no conclusion can be made as to the degree to which the device, may have caused or contributed the patient¿s reported postoperative course. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Should additional information be provided, a supplemental mdr will be submitted.
 
Event Description
The following was reported to bd by the (b)(6) health authority: (b)(6) 2020: the patient was admitted in the hospital for an indirect inguinal hernia repair. (b)(6) 2020: the patient underwent a tension-free indirect hernia repair under epidural anesthesia for the implant of a bard flat mesh. (b)(6) 2020: it was reported that the incision had redness, swelling and fluid leakage. The dressing was changed immediately and an alcohol wet compress was applied. (b)(6) 2020: the incision improved without causing any redness, swelling or fluid leakage. (b)(6) 2020: the suture was removed and also the wound healed well.
 
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Brand NameBARD FLAT MESH
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 Key10977906
MDR Text Key220504265
Report Number1213643-2020-20071
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112680
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
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: 12/09/2020 Patient Sequence Number: 1
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