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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 3INX6IN MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE MESH 3INX6IN MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PMII
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Obstruction/Occlusion (2422); Swelling/ Edema (4577); 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.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2006 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2010. It was reported that the patient experienced chronic pain, inflammation, infection, swelling, bowel obstruction and gastrointestinal malfunction. No additional information was provided.
 
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Brand NamePROLENE MESH 3INX6IN
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 Key13615347
MDR Text Key290371044
Report Number2210968-2022-01363
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K180829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial
Report Date 02/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPMII
Device Catalogue NumberPMII
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2022
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: 02/27/2022 Patient Sequence Number: 1
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