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 2016-06-08 for KETAC CEM PLUS AUTOMIX 3536 manufactured by 3m Espe Dental Products.
[46853086]
The product contains an ingredient which can trigger an allergic reaction in those individuals who are pre-sensitized to sulfites. The ifu contains information regarding this cross-reaction. It is also unclear, why the product was used on this patient a second time after a reaction was noted. Because no original material or batch-nos. Were sent to us, no further investigation on the original material or a retained sample could be performed. This product has been evaluated for biocompatibility and found to be safe for its intended use; further, it has a favorable clinical use profile with no other reports of this nature occuring this year.
Patient Sequence No: 1, Text Type: N, H10
[46853087]
3m (b)(4) was informed on may 9th, 2016, about a medical complaint involving the 3m espe relyx luting plus automix (also known as ketac cem plus automix). It was reported by a hospital that a patient experienced anaphylactic shock twice after the use of the product. According to the reporter, the root cause for the event was an allergy, but it was not specified which substance caused the symptoms. Despite several attempts, the hospital refused to provide further information, so no additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2016-00062 |
| MDR Report Key | 5707666 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-09 |
| Date Mfgr Received | 2016-05-09 |
| Date Added to Maude | 2016-06-08 |
| 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 | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS-IRVINE |
| Manufacturer Street | 2111 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KETAC CEM PLUS AUTOMIX |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2016-06-08 |
| Catalog Number | 3536 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-08 |