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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
Model Number UMS3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Swelling/ Edema (4577)
Event Date 11/08/2021
Event Type  Injury  
Event Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and the mesh was implanted. It was reported that there was post-op inflammation. It was reported that when changing the dressing two days after surgery, the incision was found to be red and swollen. Considering the rejection reaction, it improved after strengthening with systemic and local treatment. Additional information was requested.
 
Manufacturer Narrative
Product complaint # (b)(4). The provided lot number, okbbwwbo, is an invalid lot in the quality database. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: weight, bmi at the time of index procedure. Name of initial surgical procedure. The diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications. Product lot #? okbbwwbo ( is not a valid lot number in our system?) does the patient have known allergic history to medical device, food or medications? was there any allergy testing performed? if yes, results? does the surgeon believe there was any deficiency with the ethicon product involved? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
 
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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 Key13062427
MDR Text Key285624336
Report Number2210968-2021-12892
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K033337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUMS3
Device Catalogue NumberUMS3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/22/2021 Patient Sequence Number: 1
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