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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE LARGE 30X30CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. MALLA PROLENE LARGE 30X30CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PML1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)
Event Date 01/01/2022
Event Type  Injury  
Event Description
Title: application effect of temporary abdominal closure assisted by negative pressure in abdominal cavity opening with intestinal air fistula. The aim of this study was to investigate the application effect of temporary abdominal closure assisted by negative pressure in abdominal cavity opening with intestinal air fistula. A total of 82 patients with severe abdominal infection caused by intestinal fistula line open in panjin central hospital from february 2019 to february 2020 were included in the study. The patients were divided into control group (n
=
41; 18 male and 23 female; aged 43. 54 ± 7. 54 years; bmi 22. 14 ± 2. 64) and observation group (n
=
41; 21 male and 20 female; aged 42. 64 ± 8. 67 years; bmi 22. 42 ± 2. 53) according to the treatment method. The control group was treated with conventional therapy, main materials: polypropylene mesh pml1 [manufacturer: johnson & johnson medical (shanghai) ltd. , 30 cm × 30 cm], silk braided nonabsorbable suture [manufacturer home: johnson & johnson medical (shanghai) ltd. , 0# [black]. Reported complications include infection (n
=
4), colonic fistula (n
=
3), and abdominal hemorrhage (n
=
5). In conclusion, in patients with severe abdominal infection caused by intestinal fistula line open, negative pressure assisted temporary abdominal closure can effectively shorten the skin grafting time, abdominal wall reconstruction time and total hospital stay, and effectively reduce the probability of complications, which is worthy of popularization and application.
 
Manufacturer Narrative
Product complaint #: (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 obtain 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 death of the patients described in the article? does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? 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? what surgical or medical intervention has been performed? 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. Component code: (b)(4) device not returned. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Related events captured via 2210968-2022-04536. Citation: medical innovation of china (january 2022);19(2). Https://doi. Org/10. 3969/j. Issn. 1674-4985. 2022. 02. 035.
 
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Brand NameMALLA PROLENE LARGE 30X30CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key14688006
MDR Text Key294933951
Report Number2210968-2022-04535
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPML1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/14/2022 Patient Sequence Number: 1
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