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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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ETHICON INC. PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE Back to Search Results
Catalog Number 8725H
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/07/2026
Type of Reportable Event Malfunction
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Brand Name
PROLENE
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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
*   00754
Manufacturer Contact
orla o'mahony
1000 route 202
raritan, NJ 08869
3035526892
MDR Report Key25829638
Report Number2210968-2026-07236
Device Sequence Number21421618
Product Code GAW
UDI-Device Identifier10705031019799
UDI-Public(01)10705031019799(17)290228(10)UCBASX
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K133356
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Foreign,Company Representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/15/2026
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
Operator of Device Health Professional
Device Catalogue Number8725H
Device Lot NumberUCBASX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2026
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/26/2026
Initial Report FDA Received Date07/15/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured03/04/2024
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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