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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Urinary Retention (2119); Unspecified Tissue Injury (4559)
Event Date 06/18/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts are being made to clarify 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 (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 product involved? (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: thanh xuan n, huu son n (june 18, 2020) laparoscopic transabdominal preperitoneal technique for inguinal hernia repair in adults. Cureus 12(6): e8692. Doi 10. 7759/cureus. 8692.
 
Event Description
Title: laparoscopic transabdominal preperitoneal technique for inguinal hernia repair in adults. The aim of this prospective study was to evaluate the safety and early outcomes of the laparoscopic tapp technique for inguinal hernia repair using a prolene® mesh (ethicon). A total of 31 adult patients with 34 inguinal hernia cases including 11 indirect inguinal hernias, 19 direct hernias, 4 pantaloon hernias (combined direct/ indirect inguinal hernia), and 4 recurrent hernias. They underwent the laparoscopic transabdominal preperitoneal technique with a prolene mesh (ethicon) at the hue central hospital from december 2018 through may 2019. The mean age was 60. 4 ± 11. 8, and 96. 8% of cases were male. Strangulated hernias and incarcerated hernias accounted for 2. 9% and 8. 8% of cases, respectively. There were 17 cases of right-sided inguinal hernia (54. 8%), 11 cases of left-sided inguinal hernia (35. 5%), and 3 cases of bilateral inguinal hernia (accounting for 9. 7%). The hernia organ was released before performing on the strangulated or incarcerated hernias. A peritoneal incision was made from the anterior perianal papillae, about 3-4 cm above the deep inguinal vault dome, from outside to inside to the lateral umbilical fold. Then we separated the peritoneum to the deep inguinal opening, from the bundle of the inferior epigastric vessels, and separated the herniated sac if present then covered the deep inguinal opening and the posterior inguinal canal. Reported postoperative complications mild pain (n
=
13), moderate pain (n
=
18), subcutaneous emphysema (n
=
2), urinary retention (n
=
1) and funiculitis (n
=
1), one month outcome groin pain (n
=
1), three month outcome groin pain (n
=
1). In conclusion laparoscopic tapp surgery for inguinal hernia repair using prolene mesh has shown manycadvantages such as high aesthetics, short hospital stay, reduced pain after surgery, and fewer complications. Tapp can treat common inguinal hernias, complicated inguinal hernias, and recurrent inguinal hernias, and can resolve combined peritoneal diseases.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON, INC. SAN LORENZO
road 183, km. 8.3
san lorenzo
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11740102
MDR Text Key247909157
Report Number2210968-2021-03861
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeVM
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 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2021
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? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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