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 2017-05-10 for 3M ESPE RELYX ULTIMATE CEMENT manufactured by 3m Deutschland Gmbh.
[74889360]
At the moment it is not proven that the symptoms were definitively caused by the dental products as no further information like the results of an allergy testing are available. However, the timely correlation makes such a coincidence possible. The products contain methacrylates, which can cause allergies in very rare cases. Appropriate warnings are present in the instructions for use and in the safety data sheets of the products. This event involved two medical devices, therefore two manufacturer reports are being submitted. This device describes the second device. Manufacturer report number 9611385-2017-00005 describes the first device.
Patient Sequence No: 1, Text Type: N, H10
[74889361]
On (b)(6) 2017, 3m was notified that a (b)(6) female patient experienced a potential allergic reaction following a dental treatment which included 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement. The potential allergic reaction occurred at 09. 30 a. M. On (b)(6) 2017 shortly after the dental treatment. The symptoms were no feeling in lips and hand, shortness of breath and wheezing, and the patient was losing consciousness. Paramedics were called and the patient was admitted to the hospital. It was reported that that patient received two adrenaline nebulizer treatments. The patient fully recovered by 5 p. M. On the same day. Other dental products, including local anesthetics, were also used during the dental treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2017-00006 |
| MDR Report Key | 6559273 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-05-10 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-04-12 |
| Date Added to Maude | 2017-05-10 |
| 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 RELYX ULTIMATE CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2017-05-10 |
| Lot Number | 656796 |
| Device Expiration Date | 2018-07-31 |
| 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. Required No Informationntervention | 2017-05-10 |