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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCDG1
Device Problem Migration (4003)
Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544)
Event Date 03/01/2010
Event Type  Injury  
Manufacturer Narrative
(b)(4)   a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. If further details are received at a later date a supplemental medwatch will be sent.  .
 
Event Description
It was reported that a patient underwent a midline laparotomy abdominal hernia repair on an unknown date and the mesh was implanted. It was reported that the mesh disintegrated and continually caused infection creating sinuses and fistulas. There was an attempt to remove the device, but because it was in poor condition and parts had migrated, it was impossible to remove. It has continued to cause infection on a regular fortnightly basis for the last 5 years, since its attempted removal in (b)(6) 2016. It was also reported that the patient has been unable to sit for any period, has constant and chronic infections, has long periods in bed, has been unable to drive, and has been unable to walk any distances when infection is occurring. It was reported that since the mesh was implanted the patient suffered ongoing pain, infections, had been hospitalized for weeks at a time, and been told it could not be the surgical mesh causing the problem. The patient's 30 year old caesar scan opened displaying the mesh which had migrated to that area. The patient was immediately transferred in an attempt to remove the mesh. The patient has been admitted into palliative care for 18 months to control the pain, and been discharged from this program after 18 months. The patient has seen numerous doctors and specialists for alternative support and have more recently been under the chronic pain team. The patient has been given ordine and methadone for the last 20 months. No further information was available.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11823940
MDR Text Key265137739
Report Number2210968-2021-04626
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031047716
UDI-Public10705031047716
Combination Product (y/n)N
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2011
Device Model NumberPCDG1
Device Catalogue NumberPCDG1
Device Lot NumberBLG547
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/13/2021 Patient Sequence Number: 1
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