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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

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ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UML1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
 
Event Description
It was reported by an attorney that the patient underwent ventral hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient experienced chronic abdominal pain and hernia recurrence.No additional information is provided.
 
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Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8205512
MDR Text Key131701531
Report Number2210968-2018-77791
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Catalogue NumberUML1
Device Lot NumberKB8DHHA0
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/13/2018
Initial Date FDA Received12/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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