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

Model Number DYNJ907548

Device Problem Disconnection (1171)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2021

Event Type  Injury  

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 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.
• Type of Device: PERI-GYN
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• MDR Report Key: 12745069
• MDR Text Key: 282816163
• Report Number: 1423395-2021-00057
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 10193489494204
• UDI-Public: 10193489494204
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ907548
• Device Catalogue Number: DYNJ907548
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention