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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX E/X SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX E/X SURGICAL MESH Back to Search Results
Catalog Number UNKAA015
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348); Disability (2371)
Event Date 06/30/2017
Event Type  Injury  
Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol composix e/x may have caused or contributed to the reported event. The cause of the patient postoperative complications cannot be determined at this time. The patient's attorney alleges injuries and revision surgery; however, no details have been provided. No lot number has been provided therefore a review of the manufacturing records is not possible at this time. Information is limited. Should additional information be provided a supplemental emdr will be submitted. Not returned.
 
Event Description
The following was alleged by the patient's attorney: (b)(6) 2001: the patient underwent surgery for implant of an unspecified bard/davol composix e/x. (b)(6) 2017: the patient had unspecified injuries related to a defect in the composix e/x, and underwent revision surgery. The patient is only making a claim for an adverse patient outcome against the composix e/x. The attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. ¿.
 
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Brand NameCOMPOSIX E/X
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
jan ling
100 crossings blvd.
warwick, RI 02886
8015652663
MDR Report Key8258403
MDR Text Key133402790
Report Number1213643-2019-00316
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2019
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: 01/17/2019 Patient Sequence Number: 1
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