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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number UNKAA078
Device Problems Material Deformation (2976); Migration (4003)
Patient Problems Unspecified Infection (1930); Hernia (2240); Impaired Healing (2378)
Event Date 05/22/2018
Event Type  Injury  
Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the ventralight st mesh may have caused or contributed to the events as alleged. The maude event report did not provide contact information for the complainant, therefore at this time we are unable to request additional information. Infection and recurrence are known inherent risks of hernia repair surgery. Regarding infection and recurrence the instructions-for-use states. "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. " and "to prevent recurrences when repairing hernias, the prosthesis should be large enough to extend beyond the margins of the defect at least 3 to 5 cm. " a lot number was not provided, without this information a review of the manufacturing records is not possible. Should additional information be provided, a supplemental emdr will be submitted. The information provided by bard 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 bard. Not returned.

 
Event Description

The following was reported via maude event report (mw5078177): "abdominal mass surgery required an emergency mesh implant of a bard ventralight st. Within a week i developed a serious infection and was hospitalized. My wound did not close within 5 months. Even with assistance from a wound vac. I started having bowel problems, cysts, fevers, infections, wound drainage, teeth deterioration, pain, inflammation, bloating, swelling, heat generating from my stomach where my mesh was. I developed a hernia, and found that my mesh had dislocated and was in a ball. I also developed streptococcus b. On (b)(6) 2018, i had my mesh removed and my hernia repaired. Since the mesh was removed, i have not had an infection, my wound closed fully within 3 weeks. The pathology reported rendered on the removed, mesh came back infected and dislocated. ".

 
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Brand NameVENTRALIGHT ST MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7739800
MDR Text Key115711670
Report Number1213643-2018-02557
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA078
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
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: 08/01/2018 Patient Sequence Number: 1
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