MAUDE Adverse Event Report: RANIR PLACKERS FLSR MICRO MINT; CLASS I

Catalog Number UNKNOWN

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Myocardial Infarction (1969)

Event Date 11/01/2023

Event Type  Injury  

Event Description

Heart attack [myocardial infarction].Possible toxicity to yellow- white substance [toxicity to various agents].Ingested yellow-white substance [exposure to unspecified agent].Case narrative: this spontaneous report was received from the husband of a female consumer of unspecified age who began using plackers micro mint flossers daily for oral care years ago.On approximately (b)(6) 2023, while using the floss, the consumer possibly ingested a yellow-white oily substance that was was found in the bottom of the flosser bag.On an unknown date in (b)(6) 2023, the reporter felt the consumer experienced toxicity to the substance that was possibly ingested.On an unknown date in (b)(6) 2023, the consumer began administering an unknown dose of tymlos subcutaneously at an unknown frequency to build bones for an upcoming hip replacement.The consumer discontinued using the flossers from the unknown suspect lot on (b)(6) 2023 and began using from another unknown lot.On an unknown date in (b)(6) 2023, the consumer experienced a mild heart attack and was hospitalized for three days.The heart attack resolved after receiving unspecified treatment during the hospital stay.The consumer discontinued use of tymlos on an unspecified date in (b)(6) 2023 and contributes her heart attack to that product as it reportedly made her heart race; however, the reporter contributes the heart attack to the substance on the flossers.Additional details regarding relevant medical testing, concomitant medications, and any food or drug allergies remain unknown as the consumer declined to provide further information.As of 16nov2023, outcome of the toxicity and details regarding the hospital visit and treatment remains unknown.The complaint sample was returned and evaluated on 07dec2023 and consisted an open bag of plackers 300ct of mm of unknown batch/lot.There was an oily residue on the outside and the inside of the bag of flossers.Due to unknown lot number, further investgation was not possible.All aspects of consumer handling, shipping and storage are unknown once the product left perrigos controls and may have contributed to the complaint issue.

• Brand Name: PLACKERS FLSR MICRO MINT
• Type of Device: CLASS I
• Manufacturer (Section G): RANIR
• Manufacturer Contact: brian mccormick ; associate director, global pat; ient safety 515 eastern avenue; allegan 49010
• MDR Report Key: 18301736
• MDR Text Key: 330223795
• Report Number: 1811666-2023-00002
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2023

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Sex: Female