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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
Model Number PML
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Weight Changes (2607); Decreased Appetite (4569)
Event Type  Injury  
Manufacturer Narrative
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. (b)(4) submitted for the adverse event which occurred on (b)(6) 2014. (b)(4) submitted for the adverse event which occurred on (b)(6) 2016.
 
Event Description
It was reported by an attorney that the patient underwent removal surgery of the mesh and hernia repair surgery on (b)(6) 2013 and mesh was implanted during which the surgeon noted ¿the found extensive adhesions of the small bowel to the mesh which had not incorporated into the abdominal wall. Lysis of adhesions was performed for over an hour. ¿ it was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2014 during which the surgeon noted ¿he found the mesh floating in the hernia sac and it had detached from one side of the abdominal wall. The mesh was partially resected after adhesiolysis was performed to dissect it from the abdominal wall. ¿ it was reported that the patient underwent lysis of adhesions and resection of foreign body mesh on (b)(6) 2016 during which the surgeon noted ¿he performed adhesiolysis to free the small intestine from the abdominal wall and resected the remainder of the mesh that was stuck to the inferior aspect of the rectus fascia. The intestine was completely excluded. ¿ it was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss. The patient had had a previous mesh implanted on (b)(6) 2009 which is captured in 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 Key12307118
MDR Text Key266019251
Report Number2210968-2021-07231
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,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2011
Device Model NumberPML
Device Catalogue NumberPML
Device Lot NumberBEG268
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2009
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: 08/11/2021 Patient Sequence Number: 1
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