MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE IMPRINT 4 PENTA SUPER QUICK HEAVY; MATERIAL, IMPRESSON

Device Problems Complete Blockage (1094); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014 a potential adverse event occurred that involved the 3m espe products 3m espe pentamix lite and 3m espe imprint 4 penta super quick.During operation the mixing tip of the pentamix mixing device clogged and detached abruptly.The impression material imprint 4 penta super quick was released under pressure and the dental personal was bespattered.Nobody was injury.A sales representative of 3m (b)(4) was present at the doctor's office during the incident and reported the case.

Manufacturer Narrative

Method, results, conclusions: unfortunately the sales representative did not collect the affected products at once and the products weren't returned to 3m espe and the lot-nos are not known.Therefore no further analysis on the product or retained sample could be done.The impression material has been assessed for biocompatibility and has been found to be safe for its intended use.As two products were involved in the adverse event, two records will be sent to fda.This report (manufacturer report number: 9611385-2014-00015) describes the second suspect device.The first suspect device description is included in manufacturer report number 9611385-2014-00016.

• Brand Name: 3M ESPE IMPRINT 4 PENTA SUPER QUICK HEAVY
• Type of Device: MATERIAL, IMPRESSON
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; neuss ; GM
• Manufacturer Contact: carl-schurtz-strasse 1; neuss 41453 ; 9815270013
• MDR Report Key: 4254831
• MDR Text Key: 22268122
• Report Number: 9611385-2014-00015
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131404
• 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: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other