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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO PLUG (MEDIUM) MESH, SURGICAL, POLYMERIC

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ETHICON INC. ULTRAPRO PLUG (MEDIUM) MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UPPM6
Device Problem Material Integrity Problem (2978)
Patient Problem Hernia (2240)
Event Date 09/29/2021
Event Type  Injury  
Event Description
It was reported that a patient underwent an inguinal hernia repair on an unknown date and the mesh was implanted. It was reported that the patient experienced a recurring hernia five years post op. It was reported that the original mesh was completely gone, but the mesh fixation suture was visible. It was also reported that the mesh disappeared. Additional information was requested.
 
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. (b)(4). 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: age, gender, weight, bmi at the time of index procedure date and name of initial surgical procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications was the hernia repair associated with this event performed on primary or recurrent hernia? what was the defect size/type/location of the hernia associated with this event? mesh size and overlap? was the procedure associated with this event open or laparoscopic? if applicable in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or intra-abdominal) if applicable, closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? if applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants) were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? e. G. Graspers crimping the mesh fibers was there any triggering event prior to present recurrence? (e. G. Weight gain, sneezing, coughing, strenuous activity)? how was the recurrence diagnosed? please provide surgical findings if reoperation was conducted. Are there any pictures available? product lot # if applicable, will product be returned, return date, tracking information 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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Brand NameULTRAPRO PLUG (MEDIUM)
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 Key12724035
MDR Text Key282832874
Report Number2210968-2021-10610
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K070224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUPPM6
Device Catalogue NumberUPPM6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/29/2021
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: 10/29/2021 Patient Sequence Number: 1
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