MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-22 for IMPRINT 4 SUPER QUICK STEP LIGHT 71490 manufactured by 3m Deutschland Gmbh.
[73450409]
This event involved two products; therefore, two separate medwatch forms will be submitted. This report outlines the second device; the first device is filed under manufacturer report number 9611385-2017-00002.
Patient Sequence No: 1, Text Type: N, H10
[73450410]
On (b)(6) 2017, a dentist reported that a (b)(6) female patient experienced breathing difficulty and swelling of the stomach following use of 3m espe imprint 4 super quick heavy and 3m espe imprint 4 super quick step light impression material. No other products were used. When the symptoms occurred, the patient took 2 puffs from her albuterol inhaler that she carries for her allergy to mint flavorings, and the patient's mother gave her 2 tablets of diphenhydramine hcl 25mg (benadryl). In addition, the dentist prescribed and administered an albuterol nebulizer treatment to the patient in the office. It was reported that the patient felt well enough to leave the office. Upon follow-up by 3m. The dentist reported that the patient was fine with no further symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2017-00003 |
| MDR Report Key | 6513861 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-22 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-23 |
| Date Added to Maude | 2017-04-22 |
| 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 | IMPRINT 4 SUPER QUICK STEP LIGHT |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | ELW |
| Date Received | 2017-04-22 |
| Catalog Number | 71490 |
| 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 | 2017-04-22 |