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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Seroma (2069); Post Operative Wound Infection (2446)
Event Date 03/03/2020
Event Type  Injury  
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Brand NameULTRAPRO HERNIA PLUG UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11905491
Report Number2210968-2021-05082
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK070224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 04/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/28/2021 Patient Sequence Number: 1
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