• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSM
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2019
Event Type  malfunction  
Manufacturer Narrative
(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. Photo has been returned. A supplemental medwatch will be sent upon completion of analysis of photo. 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. Please clarify the number of packages that were found open before use.
 
Event Description
It was reported that the patient underwent an unknown procedure on an unknown date and mesh was used. Pre-operatively the mesh package was found opened before use. There were no adverse patient consequences reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
J-PAC
25 centre road
somersworth NH 03878
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8341084
MDR Text Key136250527
Report Number2210968-2019-78888
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPHSM
Device Lot Number31651J08
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-