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 2016-12-21 for 3M ESPE KETAC CEM EASYMIX 56900 manufactured by 3m Deutschland Gmbh.
[63055183]
At the date of this report it remains unclear if ketac cem easymix really caused the anaphylactic shock. The time elapsed between the dental treament and the beginning of the anaphylactic shock (several hours) and the clinical history of the product (an allergic reaction to it was never proven before) are arguments against a correlation. The dentist reported us the case in order to get the full composition of the product as the patient wants to have tested all possible causes of the adverse event. However, at the moment it can't be fully excluded that ketac cem easymix was involved in the incident and therefore the case is reported.
Patient Sequence No: 1, Text Type: N, H10
[63055184]
On (b)(6) 2016 3m (b)(4) was informed of an anaphylactic shock that occurred in a male patient after the use of the dental cement 3m espe ketac cem easymix. The reaction took place on (b)(6) 2016, some hours after the dental treatment. The patient was administered to a hospital, where he stayed for two weeks. After this he left the hospital without any ongoing symptoms. At the date of this report it is unclear if the product really caused the reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2016-00013 |
| MDR Report Key | 6196840 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-21 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-11-08 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2016-12-21 |
| 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 CEM EASYMIX |
| Generic Name | CEMENT, DENTAL, GLASSIONOMER |
| Product Code | EMA |
| Date Received | 2016-12-21 |
| Catalog Number | 56900 |
| Lot Number | 639347 |
| Device Expiration Date | 2018-10-31 |
| 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. Hospitalization; 2. Other | 2016-12-21 |