MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-06-28 for 3M ESPE KETAC UNIVERSAL APLICAP 61089 manufactured by 3m Deutschland Gmbh.
[78652726]
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.
Patient Sequence No: 1, Text Type: N, H10
[78652727]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2017-00008 |
| MDR Report Key | 6675604 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-28 |
| Date of Report | 2017-05-29 |
| Date of Event | 2017-05-29 |
| Date Mfgr Received | 2017-05-29 |
| Date Added to Maude | 2017-06-28 |
| 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 | 3M ESPE KETAC UNIVERSAL APLICAP |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2017-06-28 |
| Catalog Number | 61089 |
| Lot Number | 581724, 581871 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-06-28 |