MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-11-11 for 3M ESPE PENTAMIX LITE AUTOMATIC MIXING UNIT manufactured by 3m Deutschland Gmbh.
[5044476]
On (b)(6) 2014 a potential adverse event occurred that involved the 3m espe products 3m espe pentamix lite and 3m espe imprint 4 penta super quick. During operation the mixing tip of the pentamix mixing device clogged and detached abruptly. The impression material imprint 4 penta super quick was released under pressure and the dental personal was bespattered. Nobody was injury. A sales representative of 3m (b)(4) was present at the doctor's office during the incident and reported the case.
Patient Sequence No: 1, Text Type: D, B5
[12552808]
Method, results, conclusions: unfortunately the sales representative did not collect the affected products at once and the products weren't returned to 3m espe and the lot-nos are not known. Therefore no further analysis on the product or retained sample could be done. The impression material has been assessed for biocompatibility and has been found to be safe for its intended use. As two products were involved in the adverse event, two records will be sent to fda. This report (manufacturer report number: 9611385-2014-00016) describes the second suspect device. The first suspect device description is included in manufacturer report number 9611385-2014-00015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611385-2014-00016 |
| MDR Report Key | 4254814 |
| Report Source | 01,05 |
| Date Received | 2014-11-11 |
| Date of Report | 2014-10-16 |
| Date of Event | 2014-10-16 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2014-11-21 |
| 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 Street | CARL-SCHURZ-STRASSE 1 |
| Manufacturer City | NEUSS 41453 |
| Manufacturer Country | GM |
| Manufacturer Postal | 41453 |
| Manufacturer Phone | 9815270013 |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD D82229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D82229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE PENTAMIX LITE AUTOMATIC MIXING UNIT |
| Generic Name | AMALGAMATOR, DENTAL, AC-POWERED |
| Product Code | EFD |
| Date Received | 2014-11-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | NEUSS GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-11 |