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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 Necrosis (1971); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/25/2020
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) ¿ device not returned. 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: https://doi. Org/10. 1080/2000656x. 2020. 1856673.

 
Event Description

Title: reinforcement of the abdominal wall with acellular dermal matrix or synthetic mesh after breast reconstruction with the pedicled transverse rectus abdominis musculocutaneous flap. A prospective double-blind randomized study. The aim of the present study was to compare donor-site morbidity after reinforcement of the abdominal wall. Regarding development of bulging or hernia, abdominal muscle strength, complications, and abdominal pain hypothesizing that reinforcement with acellular dermal matrix strattice is superior to reinforcement with synthetic mesh prolene (ethicon). A total of 29 patients were included in the study. After randomization 14 patients were assigned to reinforcement of the abdominal donor-site with adm and 15 patients to reinforcement with synthetic mesh prolene (ethicon). No patients were lost to follow-up. Reported complication included bulging frequency (6. 7% ;n=1) and necrosis (n=2). In conclusion the present study did not demonstrate any statistically significant differences between treatment. Groups regarding risk of bulging or hernia, abdominal muscle strength, complications, pain or pain related qol within two years of follow-up. Although the small sample size sets limitations for drawing wide conclusions the hypothesis that reinforcement with adm is superior to synthetic mesh cannot be confirmed. Further research into methods for decreasing donor-side morbidity related to the tram flap or other rectus abdominis muscle-based flaps is needed.

 
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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 Key11712268
MDR Text Key261742550
Report Number2210968-2021-03646
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeDA
PMA/PMN NumberK962530
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 03/24/2021
1 Device Was Involved in the Event
0 PatientS WERE 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 HEALTH PROFESSIONAL
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 Received04/23/2021
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

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