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U.S. Department of Health and Human Services

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

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ETHICON INC. ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/25/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). 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: international journal of surgery 75 (2020) 47¿52, https://doi. Org/10. 1016/j. Ijsu. 2020. 01. 124. Please see article attached. 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 the ethicon products (ultrapro mesh and vypro mesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there were any deficiencies with the ethicon products involved? event related to vypro mesh reported via mw # 2210968-2021-02586.
 
Event Description
It was reported in a journal article with title: short-term outcome after ventral hernia repair using self-gripping mesh in sublay technique ¿ a retrospective cohort analysis. This retrospective study aimed to objectively evaluate the postoperative complication rate after ventral hernia repair in sublay technique and compare outcomes of self-gripping vs. Conventional sutured, non-self-gripping meshes. Between january 2011 and july 2018, 244 patients who received a ventral hernia repair (including incisional, umbilical or epigastric hernias) in rives-stoppa retromuscular mesh placement technique (sublay), were included in the study. There were 122 males and 122 females with a median age of (b)(6) years (iqr 54¿73); mean bmi was 29 kg/m2 (±5. 76). Patients were grouped according to the utilized mesh. The self-gripping mesh group was composed of 127 patients who all received a competitor¿s self-gripping mesh. While the non-self-gripping mesh group was composed of 117 patients in which 22 of them received an ultrapro mesh (ethicon), 2 received a vypro mesh (ethicon) and the others received competitors¿ non-self-gripping meshes. In the non-self-gripping mesh group, a conventional mesh was placed using sublay technique over the posterior sheath of the abdominal rectus muscle and was fixated with nonabsorbable monofilament sutures. In the self-gripping mesh group, the mesh was placed over the closed posterior fascia but underneath the abdominal rectus and oblique muscles. Due to microhooks, placed onto the posterior lamina of rectus sheath, a fixation with additional sutures was unnecessary. The anterior fascia was closed using a slowly absorbable suture. Reported complications in the non-self-gripping mesh group include surgical site infections (n-5), surgical site occurrences (n-14) that included seroma (n-8) and hematoma formation (n-6), recurrent hernia during follow-up (n-3), ileus caused by entrapped small bowel (n-2), early fascial dehiscence (n-1). One or more postoperative complication-associated surgical interventions (n-11), with surgical site occurrence requiring procedural interventions (n-9) and revisional surgery for postoperative complications (n-7). It was concluded that in sublay ventral hernia repair, the use of self-gripping meshes is associated with a higher overall complication rate and an increased rate of complication-associated surgical interventions when compared to non-self-gripping mesh placements.
 
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Brand NameULTRAPRO 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.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
AU D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11536514
MDR Text Key255340677
Report Number2210968-2021-02585
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K033337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2021
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: 03/20/2021 Patient Sequence Number: 1
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