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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH RECTANGULAR MESH, SURGICAL, POLYMERIC

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JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH RECTANGULAR MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY0715R
Device Problem Hole In Material (1293)
Patient Problems Adhesion(s) (1695); Pain (1994); Scarring (2061); Hernia (2240); No Code Available (3191)
Event Date 12/22/2016
Event Type  Injury  
Manufacturer Narrative
Patient codes: (b)(4). It was reported that following insertion the patient experienced scarring.
 
Manufacturer Narrative
(b)(4). Date sent to fda: 05/11/2017. (b)(4). To date the device has not been returned. If the device or further details are received at a later date, a supplemental medwatch will be sent.
 
Event Description
It was reported by an attorney that the patient underwent a laparoscopic incisional hernia repair on (b)(6) 2015 and mesh was implanted. On (b)(6) 2016, the patient had to undergo a revision surgery due to complications, and found to have incarcerated omentum, recurrent hernia, pain, and complication from adhesions requiring lysis. The mesh was examined and found to have a hole centrally with mesh circumferentially and was well embedded along the wound, which was debrided back. No additional information was provided.
 
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Brand NamePHYSIOMESH RECTANGULAR
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
JOHNSON & JOHNSON INTERNATIONAL
leonardo da vincilaan 15
diegem 1831
BE 1831
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6560700
MDR Text Key106607569
Report Number2210968-2017-60217
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHY0715R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2017 Patient Sequence Number: 1
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