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U.S. Department of Health and Human Services

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

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ETHICON INC. ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Anemia (1706); Edema (1820); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Urinary Retention (2119); Hernia (2240); Hematuria (2558); Blood Loss (2597); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. The single complaint was reported with multiple events. There are no additional details regarding the additional events.

 
Event Description

It was reported by clinical report from research study data that the patient underwent a hernia repair procedure on unknown date and the mesh was implanted. It was possible that the patient experienced bleeding peri-operative complication after the procedure with the use of the device and/or before the discharge of the index hospitalization, recurrent hernia re-operation within 90 days after the index hernia repair procedure, urinary retention peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization and/or edema peri-operative complication after the procedure with the use of the device and/or before the discharge of the index hospitalization. It was also possible that the patient experienced seroma, post-bleeding anemia, abscess, infection, orchitis, epididymitis and/or hematuria. There is no additional information available.

 
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Brand NameULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D2285 1
GM D22851
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9567497
MDR Text Key185896969
Report Number2210968-2020-00222
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK071249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,STUDY
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2019
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: 01/09/2020 Patient Sequence Number: 1
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