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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON / ETHICON, INC. PROLENE MESH II - 3X6 INCHES MESH, SURGICAL, POLYMERIC

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JOHNSON & JOHNSON / ETHICON, INC. PROLENE MESH II - 3X6 INCHES MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PMII
Device Problems Material Fragmentation (1261); Defective Device (2588)
Patient Problems Abdominal Pain (1685); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Neuropathy (1983); Pain (1994); Urinary Retention (2119); Numbness (2415); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/30/2014
Event Type  Injury  
Event Description
Had to have a second surgery; i had a laparoscopic left inguinal hernia repair with ethicon prolene mesh ii (pmii) on (b)(6) 2014 at (b)(6) hospital in (b)(6) performed by dr. (b)(6). Postoperatively i developed abdominal pain, groin pain, inability to empty my bladder, bladder spasms, pain with sitting, pain with standing, pain with walking, left leg numbness, left foot numbness with my foot turning white, and dyspareunia, all of which continued to get worse over time. I had surgery on (b)(6) 2019 at (b)(6) medical center by dr. (b)(6) to remove the mesh which had fragmented into pieces and entrapped blood vessels and nerves, the removal of a folded meshoma with entrapment neuropathy and infection, removal of the mesh which had adhered to my bladder, abdominal wall and other structures, and the repair of a recurrent left inguinal hernia. The ethicon prolene mesh ii is composed of polypropylene, the same composition as the ethicon physiomesh which was recalled. Prolene mesh ii is a defective and dangerous product and should be taken off the market. Excision of mesh from left abdomen: fibroadipose tissue with foreign body reaction and chronic inflammation, mesh as per gross description. Excision of left genital nerve. Excision of left ilioinguinal nerve. Excision of left ileo hypogastric nerve. "left side old mesh" is a 11. 5 x 4. 5 x 0. 2 cm pink-tan, irregular, soft tissue with cautery artifact and clear synthetic mesh. Attached is a 3. 2 x 2. 2 x 0. 8 cm yellow-tan, lobulated fibrofatty soft tissue. Sectioning reveals a pink-tan, smooth cut surface with synthetic embedded mesh. Sectioning the fat reveals a yellow homogenous and glistening cut surface. A gross photograph is taken. Fda safety report id# (b)(4).
 
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Brand NamePROLENE MESH II - 3X6 INCHES
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
JOHNSON & JOHNSON / ETHICON, INC.
MDR Report Key12615558
MDR Text Key276347631
Report NumberMW5104514
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2019
Device Model NumberPMII
Device Lot NumberHCE545
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/08/2021 Patient Sequence Number: 1
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