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

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC. MOORESVILLE TOTAL KNEE PAC

  • 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
 

MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC. MOORESVILLE TOTAL KNEE PAC Back to Search Results
Model Number DYNJ64730
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Malfunction  
Manufacturer Narrative

There is no contact information to follow up with the customer. According to the facility, the reported sponges are shredding very easily and leaving strings in the wound. It was reported there were no injuries regarding the reported incident. No follow-up care reported, related to the event. Due to the reported need for medical intervention, and in an abundance of caution, this is a mdr reportable event. The sample was returned for evaluation. Inspection of the used sample concluded, the manufacturer was unable to determine if the extra strings were attached or detached from the weave of the laps, there appears to be no damage to the received device. If additional information becomes available this report will be re-opened and re-evaluated.

 
Event Description

It was reported the sponges were shredding very easily during surgery, leaving strings in the wound.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEDLINE INDUSTRIES, INC.
Type of DeviceMOORESVILLE TOTAL KNEE PAC
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield, il
Manufacturer Contact
kathy woods
three lakes drive
northfield, il 
9317708
MDR Report Key10212524
MDR Text Key197917759
Report Number1423395-2020-00016
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 06/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDYNJ64730
Device Catalogue NumberDYNJ64730
Device LOT Number20CDB982
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/30/2020 Patient Sequence Number: 1
-
-