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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 Pain (1994); Post Operative Wound Infection (2446)
Event Date 01/26/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Adverse events will be submitted via 2210968-2021-01064, and 2210968-2021-01065. 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: surgical science , 8, 94-101; doi: https://doi. Org/10. 4236/ss. 2017. 82012. 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 ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that the ethicon products (ultrapro hernia system, vicryl suture, monocryl suture) 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? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

 
Event Description

It was reported in a journal article with title: ultra-pro hernia system for repair of primary complex inguinal hernia: should it be the technique of choice? this study is aiming to evaluate the short-term outcomes of the open repair of complex primary inguinal hernia using ultra-pro hernia system (uhs) mesh. Between november 2013 and november 2015, seventy five male patients (mean age=46. 1 years, age range=23 ¿ 81 years) with complex primary inguinal hernia were submitted to open inguinal hernia mesh repair using the uhs. During the procedure, the inlay patch was applied in the pre-peritoneal space. If the dissection is adequate, the oval patch of uhs (ethicon) (its inlay patch measures 12 × 8 cm) should be spread easily as medial as possible to cover the whole myo-pectineal orifice. The connector is passed through the deep ring and the onlay patch is then placed over the fascia transversalis with a slit made in it to pass the spermatic cord. The only patch was fixed by 3 vicryl 3/0 (ethicon) stitches: first one in its medial end close to the pubic bone with at least 1 cm of overlap, second one to fix it to the conjoint tendon at the level of the deep ring to prevent mesh rotation, and the third one fixing the slit to the inguinal ligament. The inguinal wound was closed in layers by vicryl 2/0 (ethicon) and the skin is closed by monocryl 3/0 (ethicon) in a subcuticular fashion. Reported complications included minimal post-operative pain with vas scale at day 1 of 3. 22 ± 1. 3; at week 1 of 1. 2 ± 0. 4; and at month 1 of 0. 3 ± 0. 11 (n=?) which had duration of oral analgesic use was 2. 1 ± 0. 9 days; superficial wound infection (n=2) were treated by oral antibiotics with no surgical drainage needed. In conclusion, inguinal hernia repair using uhs is an effective technique that combines the advantages of the anterior and the pre-peritoneal approaches. It improves the patient¿s quality of life with minimal recurrence rates.

 
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Brand NameULTRAPRO HERNIA SYSTEM 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
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11277198
MDR Text Key230218753
Report Number2210968-2021-01063
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeEG
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
Report Date 01/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/04/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
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: 02/04/2021 Patient Sequence Number: 1
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