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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 6INX6IN MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE SOFT MESH 6INX6IN MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SPMH
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
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Brand NamePROLENE SOFT MESH 6INX6IN
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC. -SAN LORENZO
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12708830
Report Number2210968-2021-10476
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2012
Device Model NumberSPMH
Device Catalogue NumberSPMH
Device Lot NumberZAE433
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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