MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP MEDLINE INDUSTRIES, INC.; PERI-GYN

Model Number	DYNJ907548
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the clinician was using the sponge stick when the sponge become disconnected from the plastic stick inside of the patient's vagina.The sponge was retrieved.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was not returned to the manufacturer for evaluation.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 or Problem Description
It was reported that the clinician was using the sponge stick when the sponge become disconnected from the plastic stick inside of the patient's vagina.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: PERI-GYN
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• MDR Report Key: 12745069
• Report Number: 1423395-2021-00057
• Device Sequence Number: 17275757
• Product Code: OHD
• UDI-Device Identifier: 10193489494204
• UDI-Public: 10193489494204
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ907548
• Device Catalogue Number: DYNJ907548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/03/2021
• 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