Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRRIMAX CORPORATION IRRISEPT; WOUND CLEANSER
  • 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
 

IRRIMAX CORPORATION IRRISEPT; WOUND CLEANSER Back to Search Results
Model Number ISEPT-450-USA
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Muscle Weakness/Atrophy (1967); Loss of Range of Motion (2032); Joint Dislocation (2374); Impaired Healing (2378)
Date of Event 01/29/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Irrimax is submitting this report in accordance with 21 cfr § 803.Irrimax will continue to contact reporting physician and other sources as necessary for the purpose of obtaining additional information and will, if necessary, file a follow-up report.
 
Event or Problem Description
Right knee (internal dehiscence of arthrotomy repair).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IRRISEPT
Common Device Name
WOUND CLEANSER
Manufacturer (Section D)
IRRIMAX CORPORATION
1665 lakes parkway
suite 102
lawrenceville GA 30043
MDR Report Key11475186
Report Number3005706359-2021-00007
Device Sequence Number3413339
Product Code FRO
UDI-Device Identifier10842351190002
UDI-Public10842351190002
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K202222
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberISEPT-450-USA
Device Catalogue Number9000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/10/2021
Initial Report FDA Received Date03/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age64 YR
Patient Weight77
-
-