• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 3INX6IN; MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PROLENE SOFT MESH 3INX6IN; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPMII
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2022 and the mesh was used.It was reported that the product received without ifu.There were no adverse patient consequences reported.Additional information has been requested.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.A photo of the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 08/22/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information:  h6.H6 component code: c22 - photo analysis.H3 evaluation: an analysis of a photo was submitted for evaluation.During the visual analysis the following was observed: the photograph shows a box of product opened and the ifu is not visible in the photo.Based on the photo review, no conclusion or root cause could be determined.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
 
Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample revealed that one opened box with six mesh product that pertains to product code spmii was returned for analysis.In order to evaluate the conditions of the returned sample, the box was observed completely opened and with some crushed on the corners of the box.For this reason, it was not possible to determine if the ifu was missing.No conclusion could be reached as to what caused the reported complaint.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROLENE SOFT MESH 3INX6IN
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN ANGELO
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
9083863534
MDR Report Key15230836
MDR Text Key303145911
Report Number2210968-2022-06642
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031050471
UDI-Public10705031050471
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 Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 12/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSPMII
Device Catalogue NumberSPMII
Device Lot NumberSEBCPU
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/01/2022
Initial Date FDA Received08/16/2022
Supplement Dates Manufacturer Received08/16/2022
11/16/2022
Supplement Dates FDA Received08/22/2022
12/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-