MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M¿ ASTRINGENT RETRACTION PASTE; CORD, RETRACTION

Model Number	56945
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the batch record showed this lot met all specification for product release and no deviations were found that could have caused or contributed to the reported event.A sample was not returned for analysis.A photo provided by the dentist shows a lesion located deep in the buccal fold, significantly below the alveolar rim.Therefore, causal relationship between the application of 3m astringent retraction paste and the necrosis could not be determined.Solventum will continue to monitor.
Event or Problem Description
The patient allegedly experienced a burn-like reaction shortly after 3m astringent retraction paste was applied around tooth 34.The dental professional cleaned the area, performed rinses and prescribed corsodyl for a few days but the affected area still appeared necrotic.When the patient returned for a follow-up visit on (b)(6) 2025, a hydrogen peroxide rinse was performed and oracort and dalacin were prescribed.The condition significantly improved, but a lesion remains on the root near the tooth's neck.

• Brand Name: 3M¿ ASTRINGENT RETRACTION PASTE
• Common Device Name: CORD, RETRACTION
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strasse 1; neuss 41453 ; GM 41453
• Manufacturer (Section G): 3M PLATZ; espe platz; seefeld 82229 ; GM 82229
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 21612925
• Report Number: 3008512935-2025-00002
• Device Sequence Number: 18045976
• Product Code: MVL
• UDI-Device Identifier: 04054596646407
• UDI-Public: 0104054596646407112311271725112610105
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K093721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2025
• Device Model Number: 56945
• Device Catalogue Number: 56945
• Device Lot Number: 10521076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2023
• 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 Sex: Unknown