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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP

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DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP Back to Search Results
Catalog Number UNKAA066
Event Date 04/10/2003
Event Type  Injury  
Manufacturer Narrative

The device associated with this event was originally reported to davol as a recalled composix kugel mesh; therefore, davol originally reported this event to the fda in accordance with rae 2008004. Subsequently, davol has received additional event information indicating that the associated event device is not a recalled composix kugel mesh; therefore, we are submitting this mdr based on the additional information received. There is no evidence of the alleged event in the medical records provided. Currently, it is unk whether the device may have caused or contributed to the reported event. Following the implant of the sepramesh, the pt developed an infection. While there is no indication that the mesh was the source of the reported infection, the warning section of the ifu 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. " no lot number has been provided; therefore a dhr review is not possible. Additionally, no sample was returned for evaluation. Without additional information, no conclusion can be drawn.

 
Event Description

On (b)(6) 2002: pt underwent repair of a ventral hernia with a sepramesh. On (b)(6) 2003: pt has an infected abdominal wound and underwent removal of the sepramesh.

 
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Brand NameSEPRAMESH IP
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
warwick RI
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot#1, rd#3, km 79.7
humacao PR 00791
Manufacturer Contact
anna amith
100 crossings blvd.
warwick , RI 02886
8005566756
MDR Report Key2540397
Report Number1213643-2012-00271
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 12/19/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKAA066
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received12/19/2007
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: 04/12/2012 Patient Sequence Number: 1
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