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

MAUDE Adverse Event Report: RICE CREEK MFG AIGIS-R MEDIUM 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
 

RICE CREEK MFG AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number NMRM6122
Device Problems Impedance Problem (2950); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a system implant, impedance measurements were unable to be read while the antibacterial absorbable envelope (aae) was in use. The physician decided to not use the (aae) and impedance measurements were clearly defined. No patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAIGIS-R MEDIUM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
RICE CREEK MFG
7000 central ave ne
suites g, e
fridley,mn NJ 55432
Manufacturer (Section G)
RICE CREEK MFG
7000 central ave ne
suites g, e
fridley,mn NJ 55432
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8107348
MDR Text Key129087876
Report Number3005619263-2018-00101
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150291
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model NumberNMRM6122
Device Catalogue NumberNMRM6122
Device Lot NumberR104172R23
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-