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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. SPONGE STICK IN WET SKIN SCRUB KIT

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MEDLINE INDUSTRIES INC. SPONGE STICK IN WET SKIN SCRUB KIT Back to Search Results
Catalog Number DYND70760
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 04/06/2019
Event Type  Malfunction  
Manufacturer Narrative

It was reported that during prep for a dilatation and curettage, the sponge stick (from wet skin scrub kit) came off the sponge and sponge was stuck in the patient's vagina. Per report, prior to the incident, the sponge stick was soaked with betadine paint and was immediately used to prep the patient. During inspection prior to use, it was denied that any issue with the sponge stick was identified at that time. The sponge was successfully retrieved from inside the patient's vagina through manual retrieval using the staff's fingers/hand. Due to the reported event and medical intervention required to retrieve the sponge from inside the patient's vagina, this medwatch is being filed. The sample is not available to be returned for evaluation. A definitive root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.

 
Event Description

It was reported that during prep for a dilatation and curettage, the sponge stick came off the sponge and sponge was stuck in the patient's vagina.

 
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Type of DeviceSPONGE STICK IN WET SKIN SCRUB KIT
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
bermon punzalan
three lakes drive
northfield, IL 60093
MDR Report Key8712991
MDR Text Key150277881
Report Number1417592-2019-00097
Device Sequence Number1
Product Code LRO
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 06/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYND70760
Device LOT Number181B0711
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2019
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 TREATMENT DATA
Date Received: 06/19/2019 Patient Sequence Number: 1
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