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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 UNKAA030
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Pain (1994); Scar Tissue (2060)
Event Date 06/15/2002
Event Type  Injury  
Manufacturer Narrative

As reported, the patient experienced serious chronic medical issues including pain, infection, vision impairment, broken bones and underwent subsequent surgical intervention for mesh removal. Based on the limited information provided to date, it is unclear how the reported implanted mesh impacted the patient¿s vision or resulted in bone fractures. In addition, while the implanted mesh was identified as a ¿marlex mesh¿, as reported the product code of the mesh is unknown as ¿it was common in 2002 for this hospital to cut the marlex mesh from a roll in the operating room¿. Bard/davol configuration of flat mesh (marlex mesh) is not distributed in a roll configuration, therefore, based on the description, it is unclear if the implanted mesh was a bard/davol device. With the available information, no conclusion can be made. However, infection is a known inherent risk of surgery; the warnings section of the instructions-for-use (ifu) supplied with bard/davol flat mesh states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " no lot number has been provided; therefore, a review of the manufacturing records is not possible. Note, the date of event is provided as a best estimate based on the patients reported symptoms. Should additional information be provided, a supplemental mdr will be submitted. Not returned - mesh explanted.

 
Event Description

The following was reported to (b)(6): it was reported that during a laparoscopic hernia repair procedure on (b)(6) 2002, the patient was implanted with an unspecified bard/davol ¿marlex mesh¿ (bard flat mesh). As reported, the patient has experienced serious chronic medical issues following the original surgery including: severe pain, itching, infection, vision impairment, broken bones and multiple trips to the er for life-threatening symptoms. These symptoms began in (b)(6) 2002 and the patient was assessed by multiple medical professionals. As reported, the patient underwent additional surgical procedures to remove the original mesh and extensive scar tissue, was prescribed pain medications and underwent imaging. At the present time, this patient continues to experience severe pain and other lifelong side effects. As reported, it was common in 2002 for this hospital to cut the marlex mesh from a roll in the operating room as a possible reason for lack of product information.

 
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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 Key11608069
MDR Text Key243564110
Report Number1213643-2021-20065
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberPREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA030
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
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: 04/02/2021 Patient Sequence Number: 1
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