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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE SOFT MESH 3INX6IN MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPMII
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).   a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.     additional information was requested and the following was obtained: please provide procedure name. It is stated: "one foil was used and it seems to be unsterile. " please explain how the device was defective. I. E did the foil had any hole or tear? any open or incomplete seal? did the mesh had foreign matter such as dust, moisture, blood, etc? please explain in detail. Was the mesh implanted on the patient or not? if yes, was it removed during the same procedure? were there any patient consequences? if yes, please explain in detail? answers: inguinal hernia surgery. One foil was unfolded, it is opened already. Out of six foils in that box, only one foil did not seal properly. They didn't use that mesh. There are no patient consequences.
 
Event Description
It was reported that a patient underwent an inguinal hernia repair procedure on an unknown date and the mesh was used. It was reported that prior to the procedure, the foil packaging of the device was unfolded and opened. The foil packaging was not sealed properly so the device appeared to be unsterile. The mesh was not used. There were no adverse patient consequences reported. Additional information was requested.
 
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Brand NamePROLENE SOFT MESH 3INX6IN
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 00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12243066
MDR Text Key264101317
Report Number2210968-2021-06804
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSPMII
Device Catalogue NumberSPMII
Device Lot NumberPHB146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received10/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2019
Is the Device Single Use? Yes
Type of Device Usage Initial

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