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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Seroma (2069); Urinary Retention (2119); Hernia (2240)
Event Date 07/07/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. 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. Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? if so, please specify. Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Patient demographics? 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. Events related to prolene 2¿0 sutures captured via 2210968-2021-03570. Events related to ultrapro mesh captured via 2210968-2021-03572. Events related to prolene mesh captured via 2210968-2021-03573. Events related to securestrap captured via 2210968-2021-03574. Citation: hernia (2020); 24:1093¿1098. Doi: https://doi. Org/10. 1007/s10029-020-02257-9.
Event Description
Title: does primary closure of direct inguinal hernia defect during laparoscopic mesh repair reduce the risk of early recurrence? the aim of this retrospective, single-center cohort study is to evaluate the value of primary closure of direct defects during laparoscopic inguinal hernia mesh repair in reducing the incidence of early recurrence. Between august 2016 to february 2018, a total of 53 patients (male
98. 1%; mean age
63 years; age range
44¿82 years) with a total of 75 direct inguinal hernias (unilateral
20; bilateral
33) were included in the study. In 9 (16. 9%) patients, the direct hernias were recurrent hernias and all underwent open mesh repair during the index hernia surgery. The majority of hernia repairs (63 hernias in 45 patients, 85%) were performed via the totally extraperitoneal (tep) approach. 19 patients (35. 8%) with 28 direct inguinal hernias underwent primary closure of the direct defect prior to mesh placement; while, 34 patients (64. 2%) with 47 direct hernias did not undergo primary closure. In patients who had closure of the direct defect, the hernia sac was first reduced into the preperitoneal space, followed by closure of the transversalis fascia at either side of the defect with interrupted prolene 2¿0 sutures (ethicon) extracorporeally. A 10 cm by 15 cm ultrapro partially absorbable lightweight mesh (ethicon) was used in all patients except for 3 patients where competitor or prolene meshes (ethicon) were used. All meshes were secured with the securestrap (ethicon) laparoscopic tacker except for one where a competitor tacker was used. Reported complications included in the closure group were seroma formation (n
5); post-operative retention of urine (n
23. 5%) which required insertion of a urinary catheter followed by subsequent trial of removal the following day; post-operative chronic groin pain at 1 year (n
5. 3%). While in the non-closure group, seroma formation (n
1); recurrence of hernia (n
3) which were treated with open mesh repair subsequently; post-operative retention of urine (n
10. 5%) which required insertion of a urinary catheter followed by subsequent trial of removal the following day; post-operative chronic groin pain at 1 year (n
5. 8%). In conclusion, closure of direct inguinal hernia defects during laparoscopic mesh repair has been shown to reduce the incidence of early hernia recurrence in our retrospective study but future randomized controlled trials with large numbers would enable us to draw more robust conclusions and perhaps change the way we perform laparoscopic inguinal hernia repair.
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Manufacturer (Section D)
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11700229
MDR Text Key246465269
Report Number2210968-2021-03572
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
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 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
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 Received04/30/2021
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: 04/21/2021 Patient Sequence Number: 1