MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE KETAC UNIVERSAL APLICAP; DENTAL CEMENT

Catalog Number 61089

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

In an interview with the customer it was revealed that a handling error contributed to the adverse events (the cavities were overdried).The correct handling was explained to the dentist and she will change the treatment accordingly in the future.

Event Description

On (b)(6) 2017, 3m (b)(4) was informed about adverse effects that occurred in (b)(4) after the use of the product 3m espe ketac universal aplicap.Several patients complained about post operational sensitivites and in some cases a root channel treatment was required.A follow-up interview with the dentist revealed that the adverse events were caused by a handling error.The dentist overdried during the treatment which led to the pain symptoms.

• Brand Name: 3M ESPE KETAC UNIVERSAL APLICAP
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, 82229 ; GM 82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• MDR Report Key: 6675604
• MDR Text Key: 78652726
• Report Number: 9611385-2017-00008
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 61089
• Device Lot Number: 581724, 581871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention