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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH PROTEMP PLUS CROWN AND BRIDGE, TEMPORARY, RESIN

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3M DEUTSCHLAND GMBH PROTEMP PLUS CROWN AND BRIDGE, TEMPORARY, RESIN Back to Search Results
Catalog Number 46955
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 07/25/2016
Event Type  Injury  
Manufacturer Narrative

No protemp plus sample returned for analysis and no lot number provided. Thus no further investigation can be completed. This event involved three medical devices, therefore three manufacturer reports are being submitted to fda. Suspect medical device part of this current report described the third medical device. Suspect medical device part of manufacturer reports 3005174370-2016-00085 and 9611385-2016-00010 describe the first and second medical device, respectively.

 
Event Description

On (b)(6) 2016, a dental assistant informed 3m that a (b)(6) male patient required a root canal due to unresolved sensitivity. The patient initially had a restorative treatment using 3m espe filtek z250 restorative and 3m espe scotchbond universal adhesive on (b)(6) 2016. The patient returned to the office on (b)(6) 2016 experiencing sensitivity and pain and the restorative was replaced using a non-3m liner followed by 3m espe filtek z250 restorative and 3m scotchbond universal adhesive again. The pain continued and on (b)(6) 2016, the patient saw an endodontist and was diagnosed with irreversible pulpitis and was recommended for a temporary crown. On (b)(6) 2016, the dental office placed a temporary crown using 3m espe protemp plus with a non-3m brand cement. On (b)(6) 2016 the patient reported that the pain had worsened and on (b)(6) 2016, the root canal was performed.

 
Manufacturer Narrative

Suspect medical device part of manufacturer reports 3005174370-2016-00086 and 9611385-2016-00010 describe the first and second medical device, respectively.

 
Event Description

On october 6, 2016, the dental office reported that the patient was doing well.

 
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Brand NamePROTEMP PLUS
Type of DeviceCROWN AND BRIDGE, TEMPORARY, RESIN
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 Key5905476
MDR Text Key53062577
Report Number9611385-2016-00011
Device Sequence Number1
Product Code EBG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073296
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation DENTIST
Type of Report Initial,Followup
Report Date 10/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator DENTIST
Device Catalogue Number46955
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/26/2016 Patient Sequence Number: 1
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