MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-08 for RELYX LUTING PLUS AUTOMIX CEMENT 3535 manufactured by 3m Espe Dental Products.
[39928717]
Engineering investigation was limited due to lack of returned product and lot number information. This event involved two 3m espe medical devices, therefore two manufacturer medwatch reports are being submitted. This medwatch report provides information on the second medical device. Manufacturer report 9611385-2016-00003 provides information on the first medical device. Both 3m subject products have been evaluated for biocompatibility and are safe for their intended use. Without additional information on patient medical history, the cause of the reported reaction cannot be determined. Relyx luting plus automix cement contains potassium persulfate which can trigger an allergic respiratory reaction in certain pre-sensitized individuals (those individuals already sensitized to sulfites). The instructions for use for relyx luting plus automix cement and safety data sheet both contain a warning for the potential cross-reaction. In the last seven years, 3m has received only three other reports of possible respiratory reaction for the product.
Patient Sequence No: 1, Text Type: N, H10
[39928718]
A medical office reported a (b)(6) patient experienced anaphylactic shock after use of 3m espe scotchbond universal adhesive and 3m espe relyx luting plus automix cement. Contact information for the medical office was inadvertently not obtained during the call. 3m contacted the treating dental office and they were unable to identify the patient involved in this case; therefore no further information is available, and the relationship of the symptoms reported to use of the 3m subject products cannot be established.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2016-00031 |
| MDR Report Key | 5487670 |
| Date Received | 2016-03-08 |
| Date of Report | 2016-02-10 |
| Date Mfgr Received | 2016-02-10 |
| Date Added to Maude | 2016-03-08 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | RELYX LUTING PLUS AUTOMIX CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2016-03-08 |
| Catalog Number | 3535 |
| 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. Life Threatening | 2016-03-08 |