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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH DART SURGICAL MESH Back to Search Results
Catalog Number 0112730
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Hernia (2240)
Event Date 01/12/2006
Event Type  Injury  
Manufacturer Narrative
Per patient medical records, post 2005 implant of the bard/davol dart mesh, the patient experienced a recurrent hernia in 2006 and underwent surgical intervention, at which time an additional non-bard/davol mesh was placed. During a subsequent 2009 procedure for the repair of another recurrent hernia the medical records note the explant of a torn previously placed hernia mesh. There is no indication in the jan2006 operative report that the previously 2005 implanted bard/davol dart mesh was encountered during the ¿recurrence¿ repair. In addition, the initial reporter limited the adverse event allegation claim to the 2006 implanted non-bard/davol mesh and did not make any allegation of adverse event related to the bard/davol dart mesh. Though not discernable from the limited hernia location descriptions in the operative reports, it is possible that the 2006 ¿recurrence¿ repair is in a noticeably identifiable location in relation to the initial 2005 bard/davol dart mesh hernia repair site. However, based on the provided operative reports, it remains unclear which previously implanted mesh was alleged to have torn and was explanted during 2009 index procedure. Based on the information available, no conclusions can be made. Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for-use supplied with the device as a possible complication. Review of manufacturing records indicates product was manufactured to specification, with no indication of a manufacturing related cause for the event reported. Should additional information be provided, a supplemental mdr will be submitted. Mesh explanted.
 
Event Description
Per medical records: on (b)(6) 2005 patient underwent repair of an epigastric hernia with implant of a bard/davol dart mesh. On (b)(6) 2006 the patient underwent repair of a recurrent epigastric hernia with implant of a non bard/davol manufactured sepramesh ip. The operative report does not indicate that the previously implanted dart mesh was encountered during this repair. On (b)(6) 2009 the patient underwent repair of a recurrent incisional ventral hernia with implant of a non-bard/davol biologic mesh. The operative report states that during this procedure an "incarcerated torn hernia mesh" was encountered which was explanted during the procedure.
 
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Brand NameMESH DART
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 Key12490903
MDR Text Key272655000
Report Number1213643-2021-20333
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2005
Device Catalogue Number0112730
Device Lot Number43IKD356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2000
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: 09/17/2021 Patient Sequence Number: 1
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