MAUDE Adverse Event Report: ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH CORA; TAMPON

Model Number	SUPER PLUS
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On the first day of heavy bleeding, she used a super plus tampon.After removing it, she noticed that only the barrel remained and felt smaller than expected.She checked inside but couldn't feel anything, so she inserted another tampon.Each time she removed a tampon, she checked with her fingers, but felt nothing unusual internally.Over the next few days, she experienced increasing nausea and uterine pain, with her cramps getting worse.Eventually, she had difficulty bending and walking.While urinating, she coughed and felt something foreign inside.Upon reaching in, she detected a plastic-like object.At the er, the doctor performed a pap smear and used a speculum, discovering a tampon applicator stuck sideways.The doctor noted swelling and scratches, and said it would have been impossible for her to remove it on her own.The applicator was lodged inside her for 6 days.No medication was prescribed.

• Brand Name: CORA
• Common Device Name: TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstrasse 30; grosspostwitz, saxony 02692 ; GM 02692
• MDR Report Key: 20311877
• Report Number: 3012097557-2024-00002
• Device Sequence Number: 8838026
• Product Code: HEB
• UDI-Device Identifier: 00810042480520
• UDI-Public: (01)00810042480520(17)2028-03-19(10)LOTWP415001F2
• 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: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2024
• Report Date (Section F): 09/26/2024

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: Lay User/Patient
• Device Model Number: SUPER PLUS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/04/2024
• Event Location: Home
• Date Report to Manufacturer: 09/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2024
• 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
• Patient Age: 31 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/26/2024