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

Catalog Number	DYND70760
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/06/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Common Device Name: SPONGE STICK IN WET SKIN SCRUB KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8712991
• Report Number: 1417592-2019-00097
• Device Sequence Number: 19288129
• Product Code: LRO
• UDI-Device Identifier: 10080196853236
• UDI-Public: 10080196853236
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND70760
• Device Lot Number: 181B0711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention