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 2017-04-12 for 3M ESPE IMPREGUM PENTA manufactured by 3m Deutschland Gmbh.
[72619183]
At the moment it is not clear whether or not the reported symptoms are linked to the use of the 3m product, since multiple products were used in the same appointment and the patient is known to have multiple allergies (e. G. Against nickel, baume du prou, eugenol, glutaraldehyde, penicillin, bactrim, xylocaine, tetracaine). The other products from the affected batch show no unusual complaint history or trending. However, as it can also not be excluded that impregum penta caused the adverse effect, we decide to report this case. In the last follow-up call with the dentist it was confirmed that the patient is doing well again, but no additional information was available.
Patient Sequence No: 1, Text Type: N, H10
[72619184]
On march 13, 2017 3m (b)(4) was informed about an adverse effect that occurred in (b)(6) after the use of the product 3m espe impregum penta. One hour after the patient got the dental treatment she began to suffer from reddening and swelling in the mouth, accompanied from pain and breathing difficulties. The patient sought ambulant help in a hospital. She was treated with corticoids, antihistaminics, and aspirin to rinse the mouth. After this the symptoms declined and vanished completely after three days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2017-00004 |
| MDR Report Key | 6487319 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-04-12 |
| Date of Report | 2017-03-13 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2017-03-13 |
| Date Added to Maude | 2017-04-12 |
| 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 IMPREGUM PENTA |
| Generic Name | POLYETHER IMPRESSION MATERIAL |
| Product Code | ELW |
| Date Received | 2017-04-12 |
| Lot Number | B624701 |
| Device Expiration Date | 2018-10-01 |
| 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. Required No Informationntervention | 2017-04-12 |