MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS IMPRINT 3 QUICK STEP HEAVY BODY VPS IMPRESSION; MATERIAL, IMPRESSION

Catalog Number 10971

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/11/2014

Event Type  Injury  

Event Description

Male patient in his late 20s presented himself to the emergency room on (b)(6) 2014 at approximately 12:30 am with 3m espe imprint 3 quick step heavy body vps impression material injected into his urethra.The urologist incised the end of the penis and pulled 10-12 inches of cured impression material out; patient was sutured and sent home with post operative medications.The urologist reported the patient is fine and will be seen in two weeks for suture removal.

Manufacturer Narrative

Based on the information available to 3m espe, it is unclear how the person obtained the dental impression material.

• Brand Name: IMPRINT 3 QUICK STEP HEAVY BODY VPS IMPRESSION
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; saint paul MN
• Manufacturer Contact: 2510 conway avenue; saint paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 4218739
• MDR Text Key: 5002674
• Report Number: 3005174370-2014-00033
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 10971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention