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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 Diarrhea (1811); Fever (1858); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Pneumonia (2011); Renal Failure (2041); Seroma (2069); Perforation of Vessels (2135); Hernia (2240); Impaired Healing (2378); Cardiovascular Insufficiency (4445); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Event Date 05/09/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Date sent to the fda: 06/06/2022. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. (b)(4). This report is related to a clinical evaluation report from a related research activity database; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events.
 
Event Description
This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing inguinal hernia repair. The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 13 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, intraoperative complications (total). 8 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, bleeding. 7 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, organ injuries. 2 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, vascular. 1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, bladder. 4 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, nerve (inguinal). 1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, others. 15 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, general complications (total). 4 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, fever. 1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, diarrhea. 1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, pneumonia. 1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, cardiac insufficiency. 2 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, coronary heart disease. 1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, renal insufficiency. 1 patient had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, hypertensive crisis. 8 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, others. 96 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, postoperative complications (total). 36 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, bleeding. 53 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, seroma. 6 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, wound healing disorder. 4 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, infection. 13 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, complication-related operations. 19 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, recurrence on 1-year follow-up. 279 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, pain on exertion on 1-year follow-up. 142 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, pain at rest on 1-year follow-up. 68 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, pain requiring treatment on 1-year follow-up. 2 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, trocar hernia on 1-year follow-up. 24 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, secondary hemorrhage on 1-year follow-up. 35 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, seroma on 1-year follow-up. 19 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, infection on 1-year follow-up.
 
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Brand NameULTRAPRO HERNIA SYSTEM 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 2284
GM 2284
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key14606582
MDR Text Key293449221
Report Number2210968-2022-04335
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071249
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

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