MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-07 for 3M ESPE POLYETHER ADHESIVE 30600 manufactured by 3m Deutschland Gmbh.
[18569998]
After a dental impression using the 3m espe products 3m espe permadyne h, 3m espe permadyne l, and 3m espe polyether adhesive a pt suffered from strong swelling and reddening in the areas of the neck and the cheeks. Additionally she had a numb feeling in the tongue. All symptoms vanished after three days. The symptoms were rated serious by the dentist.
Patient Sequence No: 1, Text Type: D, B5
[18705807]
As noted in the event description of this report, three suspect devices were involved in the current event, therefore, this report includes the third suspect device and the other two suspect device descriptions are included in mfr report numbers 9611385-2013-00011 and 9611385-2013-00012, respectively. The suspect device noted in this report has not been returned to 3m espe. The analysis of a retained sample of the same lot showed no particularity. This product has been assessed for biocompatibility and has been found to be safe for its intended use. The dentist stated that there was already an intolerance reaction when the products were applied to the pt in the yr 1996, but at this time there were only mild symptoms. Therefore, it can be assumed, that there's underlying allergic reaction. This time the symptoms were also not life-threatening, but rated as severe by the dentist.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611385-2013-00013 |
| MDR Report Key | 3310620 |
| Report Source | 05 |
| Date Received | 2013-08-07 |
| Date of Report | 2013-06-27 |
| Date of Event | 2013-05-22 |
| Date Mfgr Received | 2013-06-27 |
| Date Added to Maude | 2013-08-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR THOMAS MEINDL |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal | 82229 |
| Manufacturer Phone | 981527001. |
| Manufacturer G1 | 3M DEUTSCHLAND GMBH |
| Manufacturer Street | CARL-SCHURZ-STRASSE 1 |
| Manufacturer City | NEUSS 41453 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 41453 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE POLYETHER ADHESIVE |
| Generic Name | POLYETHER ADHESIVE |
| Product Code | EBH |
| Date Received | 2013-08-07 |
| Catalog Number | 30600 |
| Lot Number | 490285 |
| Device Expiration Date | 2015-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | SEEFELD GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-07 |