MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP TRAY,SKIN SCRUB,PREMIUM,WET,LF

Model Number	DYND70660
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the facility that a patient experienced a vaginal tear after prepping with a skin scrub prep stick.Per the facility the patient was positioned in a lithotomy position while under anesthesia and the physician performed a vaginal check prior to the procedure.After the manual check was performed the peri area was prepped as well as the vaginal vault.Prior to the drapes being applied there was blood noted to be coming from the vagina.The physician performed an inspection and a posterior tear was noted.Per the facility the physician cancelled the scheduled procedure and performed a laceration repair with sutures while under anesthesia.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 any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported by the facility that a patient experienced a vaginal tear after prepping with a skin scrub prep stick.The physician cancelled the scheduled procedure and performed a laceration repair with sutures while under anesthesia.

• Brand Name: TRAY,SKIN SCRUB,PREMIUM,WET,LF
• Common Device Name: TRAY,SKIN SCRUB,PREMIUM,WET,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15136732
• Report Number: 1417592-2022-00124
• Device Sequence Number: 12586754
• Product Code: OJU
• UDI-Device Identifier: 10080196998616
• UDI-Public: 10080196998616
• Combination Product (Y/N): N
• 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): 07/30/2022

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: DYND70660
• Device Catalogue Number: DYND70660H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female