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U.S. Department of Health and Human Services

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

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ETHICON INC. ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number ULTRAHSUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Discomfort (2330); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)
Event Date 08/29/2018
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). Date sent to the fda: 2/19/2020 component code: g07002 - device not returned 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: kitasato med j 2019; 49: 16-20   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 product (ultrapro hernia system) 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 product involved?.

 
Event Description

It was reported in a journal article with title: clinical estimation of the tapp laparoscopic surgery versus the conventional procedure for inguinal hernia and the efficacy of reducing the number of tacking fixations of intra-abdominal devices. The study discussed about the clinical estimation of the transabdominal preperitoneal (tapp) laparoscopic surgery versus the conventional procedure for inguinal hernia and the efficacy of reducing the number of tacking fixations of intra-abdominal devices. A total of 134 patients underwent either a conventional open procedure or tapp from march 2011 through november 2015. Forty-five conventional open procedures (male=43, female=2; mean age=72. 0 ± 12. 6 years) and 89 tapp procedures (male=77, female=12; mean age=68. 2 ± 14. 3) were included in the study. During the procedure, polypropylene mesh, such as ultrapro hernia system (ethicon), perfix light plug, and kugel patch was used in the conventional group after spinal anesthesia. These meshes were sheeted into an overlay and/or underlay of the preperitoneal space by the anterior approach and were fixed with stitches. Reported complications included corona mortis injury (n=?); wound infection (n=?); subcutaneous hematoma (n=?); chronic pain (n=?); and discomfort (n=?). In conclusion, using the tapp procedure, chronic pain was significantly reduced. It was also made evident that fewer tack points made for mesh fixation in hernia repairs would further reduce discomfort.

 
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Brand NameULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08876
9082182213
MDR Report Key11347232
MDR Text Key239139806
Report Number2210968-2021-01592
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK071249
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 01/20/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULTRAHSUNK
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 Received04/04/2021
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: 02/19/2021 Patient Sequence Number: 1
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