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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 Seroma (2069); Urinary Retention (2119); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/31/2020
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? (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: journal of family medicine and primary care volume 9 : issue 5 : may 2020.
 
Event Description
Title: does laparoscopic hernia repair affect the vascularity of testis? in this study, we attempt to evaluate the effects of laparoscopic total extraperitoneal (tep) repair on testicular blood flow in indian population by comparing the testicular perfusion in preoperative and postoperative. From january 2018 to january 2019, a total of 100 sides were operated in 80 patients. The average age of these patients was 50. 2 ± 13. 3 years (range 24¿72 years). Nearly 60 of these patients were clinically diagnosed to have a unilateral hernia (40 right-sided and 20 left-sided, 36 indirect, and 24 direct hernias) and 20 to have a bilateral hernia (36 direct and 4 indirect) (distribution of hernia [laterality] and type of hernia). Eventually, 60 patients underwent a unilateral repair and 20 patients underwent bilateral repair. A 15*13 cm sized prolene mesh was used in all cases. 8 cases had peritoneal breach. 1 case had urinary bladder injury that was detected on 1st postoperative day when the patient did not void after removal of the catheter, on ct scan a 3 mm rent was diagnosed on the anterolateral aspect, the patient was managed conservatively by reinserting 20 fr. Size foley catheter for 21 days. 1 patient had inferior epigastric artery injury which was managed intraoperatively by monopolar coagulation. 4 patients had pneumo scrotum which resolved within 48h, 2 patients had seroma which resolved within 4 weeks and 1 patient had urinary retention which required recatheterization. Tep repair is a safe procedure in an experienced hand, it does not hamper the vascularity of the testes, and care should be taken during a dissection of the hernia sac from the cord structure. Further studies with a bigger sample size and longer follow-up are required to evaluate the long-term effect.
 
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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 PR
982 road 183 km 8.3
san lorenzo
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11710322
MDR Text Key246810379
Report Number2210968-2021-03664
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
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 Received05/07/2021
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

Patient Treatment Data
Date Received: 04/22/2021 Patient Sequence Number: 1
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