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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Pneumonia (2011); Seroma (2069); Urinary Retention (2119); Hernia (2240); Thrombosis/Thrombus (4440); Alteration in Body Temperature (4568); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/22/2019
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. Additional information was requested and the following was obtained: 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. Anything you need to know about this is documented in the manuscript. I do not think it had anything to do with the products. Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details. Anything you need to know about this is documented in the manuscript. I do not think it had anything to do with the products. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Not provided. Patient demographics? as a federal facility i cannot provide any patient protected information (demographics). (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. Events related to 3-0 vicryl suture captured via 2210968-2021-03501. Events related to 0-pds suture captured via 2210968-2021-03503. Citation: https://doi. Org/10. 1016/j. Jss. 2019. 03. 046.
Event Description
Title: open, laparoscopic, and robotic inguinal hernia repair: outcomes and predictors of complications this restrospective study aimed to compare outcomes of inguinal hernia repair as performed by an expert in each approach. A total of 1299 inguinal hernia repairs performed at the (b)(6) health care system between 2005 and 2017 was undertaken. Three surgeons performed the operations, each an expert in one approach, and there was no crossover in techniques. A total of 1100 ohrs, 128 lhrs, and 71 rhrs were performed. Patient demographics were similar among groups except for age that was higher in the ohr cohort. Univariable analysis was undertaken to determine associations between techniques and outcomes (ohr versus lhr; ohr versus rhr; lhr versus rhr. Setting complications as a dependent variable, multivariable analyses were undertaken to determine an association with complications as well as independent predictors of complications. During ohr, once the ilioinguinal nerve is identified, it is divided and ligated at themost proximal end with 3-0 vicryl (ethicon). Indirect hernias undergo isolation of the sac and the hernia sac is opened and ligated or reduced if a sliding component is suspected. The floor is imbricated with 0-vicryl (ethicon) if there is a protruding direct component. The floor is then repaired with a 6. 0x3. 0 inch polypropylene mesh (ethicon inc, somerville, nj) that is cut in a cone configuration to accommodate the size of the inguinal floor by creating tails around the cord structures. This is secured inferiorly to the shelving edge of the inguinal ligament with 0- pds (ethicon) in a running fashion and superiorly to the conjoint tendon with interrupted 0-ethibond sutures (ethicon). Reported complications included recurrence (n
19),post-op pain beyond 3 months/ inguinodynia (n
16), inguinal pain (n
9), urinary retention (n
20), ileus (n
8), ischemic orchitis (n
3), hematoma/seroma (n
29), fever (n
8), acute kidney injury (n
8), delirium (n
8), bowel perforation (n
2), aspiration pneumonia (n
2) and deep vein thrombosis (n
2). The average follow-up was 5. 2 ¿ 3. 4 y. Average follow-up was longer in the ohr than in the lhr(5. 6 3. 6 y versus 3. 9 1. 8 y; p < 0. 001). It was also longer than that in the rhr (5. 6 3. 6 y versus 2. 4 0. 8 y; p < 0. 001). In the present report, recurrence was associated with a higher rate in the rhr versus ohr (5. 6% versus 1. 7%; p < 0. 02), but not in the lhr versus ohr (3. 9% versus 1. 9%; p
0. 09). Inguinodynia was more likely to occur in both the lhr and rhr compared with the ohr (9. 4% and 14. 1 versus 1. 5%; both p's < 0. 001). Urinary retention was also more common in the lhr and rhr than in the ohr (5. 5% and 5. 6% versus 1. 8%, both p's < 0. 05) as was the rate of overall complications (34. 4% and 38. 0% versus 11. 2%, both p's < 0. 001). In conclusion, outcomes in the ohr cohort were, in general, superior compared with both the lhr and rhr. However, this study is not to show that one approach should be performed over another, these strategies should be viewed as complementary. The best approach to an inguinal hernia repair rests on the specific expertise of the surgeon.
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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 Key11687486
MDR Text Key262219974
Report Number2210968-2021-03502
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
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 Received03/26/2021
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
Removal/Correction NumberN/A