• 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.; DENTIPS FOAM SWAB

  • 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.; DENTIPS FOAM SWAB Back to Search Results
Catalog Number MDS096502
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/28/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that a sponge fell off inside of a patient during oral care and was not able to be retrieved.The facility reported that the nurse completed oral care with swab and hydrogen peroxide rinse packet.Upon rinsing the sponge in the peroxide, the nurse reported the sponge was completely intact prior to oral care.The patient was noted to be intubated, sedated, and paralyzed due to significant trauma injuries and respiratory status.Patient was paralyzed and did not attempt to "chew" on swab.Upon removal of swab from the patient's mouth the swab was found to have lost a large section of the sponge on the bottom of the stick.Oral inspection and scope inspection were completed with no sign of a sponge.The following day the patient required a bronchoscope and again no swab was found upon inspection.There was no reported serious injury or follow up medical care required related to the reported incident.The patient is reportedly doing fine.The sample is not available, however pictures have been made available for evaluation.No additional information is available.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported that a sponge fell off inside of a patient during oral care and was not able to be retrieved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
DENTIPS FOAM SWAB
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093
MDR Report Key11229381
MDR Text Key228649569
Report Number1417592-2021-00008
Device Sequence Number1
Product Code KXF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMDS096502
Was Device Available for Evaluation? No
Date Manufacturer Received12/29/2020
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age34 YR
Patient Weight73
-
-