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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 20X30CM RECT MESH, SURGICAL

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ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 20X30CM RECT MESH, SURGICAL Back to Search Results
Catalog Number PHY2030R
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fatigue (1849); Pain (1994); Vomiting (2144); Hernia (2240); Injury (2348); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
Patient code: (b)(4) - surgical intervention. Device problem: (b)(4) - hernia recurrence occurred. Additional narrative: it was reported that patient underwent mesh removal on (b)(6) 2015 by dr. (b)(6) at (b)(6) medical center due to recurrent hernia. No additional information was provided.
 
Manufacturer Narrative
It was reported that following insertion the patient experienced pain and abdominal pain.
 
Manufacturer Narrative
Patient codes: (b)(4). It was also reported that the patient experienced nausea, fatigue, infection, vomiting, ascites, constipation, and adhesions. It was also reported that the patient underwent mesh removal surgery on (b)(4) 2015. No additional information was provided.
 
Manufacturer Narrative
Date sent to fda: 7/1/2019.
 
Manufacturer Narrative
(b)(4). Undefined device problem. 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.
 
Event Description
It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2014 and mesh was implanted. It was reported that the patient experienced an undisclosed adverse event. No additional information was provided.
 
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Brand NameETHICON PHYSIOMESH COMPOSITE MESH 20X30CM RECT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
MDR Report Key7244527
MDR Text Key107029969
Report Number2210968-2018-70407
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2015
Device Catalogue NumberPHY2030R
Device Lot NumberGP8DKPB0
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/06/2018 Patient Sequence Number: 1
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