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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PROMESHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Scarring (2061); Seroma (2069); Not Applicable (3189)
Event Date 09/17/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Adverse events will be submitted via mw# 2210968-2020-08748, mw# 2210968-2020-08749. This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: aesthetic surgery journal 2018, vol 38(6) 635¿643; doi: 10. 1093/asj/sjx175; published online: october 14, 2017. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon products (prolene suture, ethilon suture, prolene mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved?.
 
Event Description
It was reported in a journal article with title: the suprapubic dermoadipose flap for aesthetic reshaping of the postpregnancy abdomen. This study reports preliminary experiences with a simple, although overlooked, surgical resource designed to prevent late postoperative contour deformities in slim women undergoing abdominoplasties and presenting severe recti abdominis diastasis associated with midline subcutaneous fat atrophy. Between january 2005 and january 2015, twenty-two female patients (ages ranged from 19 to 36 years; mean, 27 years) undergoing abdominoplasty with the suprapubic flap were included in the study. Rectus sheaths were reinforced by vertical plication from the xiphoid process to the pubis with inverted 2-0 polypropylene mattress sutures (prolene, ethicon, somerville, nj). In selected multiparous patients with wide diastasis recti and musculoaponeurotic laxity, an additional abdominal wall reinforcement was indicated by using an onlay polypropylene mesh (prolene, ethicon). Afterwards, the umbilicus was fixed to the fascia with inverted monofilament nylon 4/0 knotted stitches (ethilon, ethicon). The suprapubic flap was then sutured back to the recti abdominis muscle fascia, covering the lower plication area and occupying the infraumbilical area, which requires tissue filling. After the placement of drains, the abdominal incision was closed in three layers with 3/0, 4/0, and 5/0 monofilament nylon sutures (ethilon). Complications included hematoma (n
=
1) which required a return to the operating room for evacuation; seroma (n
=
1) which required evacuation; skin slough (n
=
1) and hypertrophic scarring (n
=
3). The case of minimal skin slough healed after conservative treatment with wound dressings. Cases of hypertrophic scarring at the medial area was resolved with serial injections of triamcinolone with a 2-week injection interval. In conclusion, the suprapubic dermoadipose flap is an effective option to prevent the midline depression that would otherwise remain on the hypogastric region of post-pregnant slim women with midline fat tissue atrophy.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183
km 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10798196
MDR Text Key217358458
Report Number2210968-2020-08750
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 10/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPROMESHUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/06/2020 Patient Sequence Number: 1
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