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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 Migration (4003)
Patient Problems Adhesion(s) (1695); Erosion (1750); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Neuropathy (1983); Pain (1994); Hernia (2240); Numbness (2415)
Event Date 05/02/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Device not returned. A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. To date no response has been provided. 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 laparoscopic left inguinal hernia repair on an unknown date in 2014 and the mesh was implanted. It was reported that the patient had to have a second surgery. It was reported that postoperatively, the patient developed abdominal pain, groin pain, inability to empty bladder, bladder spasms, pain with sitting, pain with standing, pain with walking, left leg numbness, left foot numbness with foot turning white, and dyspareunia, all of which continued to get worse over time. It was reported that the patient had surgery on an unknown date in 2019 to remove the mesh which had fragmented into pieces and entrapped blood vessels and nerves, remove folded meshoma with entrapment neuropathy and infection, remove mesh which had adhered to the bladder, abdominal wall and other structures, and repair a recurrent left inguinal hernia. It was reported that the mesh was a defective and dangerous product. It was also reported that the patient experienced excision of mesh from left abdomen: fibroadipose tissue with foreign body reaction and chronic inflammation, mesh as per gross description. It was reported that the patient experienced excision of left genital nerve, excision of left ilioinguinal nerve, and excision of left ileo hypogastric nerve. It was reported that the "left side old mesh" is a 11. 5 x 4. 5 x 0. 2 cm (b)(6), irregular, soft tissue with cautery artifact and clear synthetic mesh. A 3. 2 x 2. 2 x 0. 8 cm (b)(6), lobulated fibrofatty soft tissue was described. It was also described that sectioning revealed a pink-tan, smooth cut surface with synthetic embedded mesh. Also, sectioning the fat revealed a (b)(6) homogenous and glistening cut surface.
 
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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 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12914531
MDR Text Key286367356
Report Number2210968-2021-12259
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,Consumer
Reporter Occupation
Type of Report Initial
Report Date 12/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Model NumberPMII
Device Catalogue NumberPMII
Device Lot NumberHCE545
Was Device Available for Evaluation? No
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/13/2014
Is the Device Single Use? Yes
Type of Device Usage Initial

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