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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE* POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Diarrhea (1811); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Chills (2191); Weight Changes (2607); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2008. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2009. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2009.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted. It was reported that the patient underwent removal surgery of the mesh on (b)(6) 2008. It was reported that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted. It was reported that the patient underwent removal surgery of the mesh on (b)(6) 2009 during which the surgeon noted the mesh was removed due to infection from the grossly contaminated outer lawyer of necrotic abdominal wound. It was reported that the patient experienced infection, small abscess cavity with drainage, severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. Other procedure is captured under separate file. No additional information was provided.
 
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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.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12254046
MDR Text Key264470162
Report Number2210968-2021-06866
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2011
Device Catalogue NumberPMH
Device Lot NumberXPP023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/29/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/30/2021 Patient Sequence Number: 1
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