MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-26 for PROTEMP PLUS 46955 manufactured by 3m Deutschland Gmbh.
[53062577]
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.
Patient Sequence No: 1, Text Type: N, H10
[53062578]
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.
Patient Sequence No: 1, Text Type: D, B5
[59246970]
Suspect medical device part of manufacturer reports 3005174370-2016-00086 and 9611385-2016-00010 describe the first and second medical device, respectively.
Patient Sequence No: 1, Text Type: N, H10
[59246971]
On october 6, 2016, the dental office reported that the patient was doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2016-00011 |
| MDR Report Key | 5905476 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-26 |
| Date of Report | 2016-10-06 |
| Date of Event | 2016-07-25 |
| Date Mfgr Received | 2016-10-06 |
| Date Added to Maude | 2016-08-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. THOMAS MEINDL |
| Manufacturer Street | CARL-SCHURZ-STRASSE 1 |
| Manufacturer City | NEUSS, 41453 |
| Manufacturer Country | GM |
| Manufacturer Postal | 41453 |
| Manufacturer G1 | 3M DEUTSCHLAND GMBH-SEEFELD |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD, 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 82229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTEMP PLUS |
| Generic Name | CROWN AND BRIDGE, TEMPORARY, RESIN |
| Product Code | EBG |
| Date Received | 2016-08-26 |
| Catalog Number | 46955 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | CARL-SCHURZ-STRASSE 1 NEUSS, 41453 GM 41453 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-26 |