MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2009-05-12 for NONE manufactured by Nopa Instruments, Medizintechnik Gmbh.
[2762118]
.
Patient Sequence No: 1, Text Type: D, B5
[10119622]
Despite repeated attempts of our distributor, the device was not returned for investigation. The dentist involved in this incident, is reluctant to return the instrument because it is needed. It was purchased two years ago and according to the info received, functions perfectly. The tip that was retrieved in subject procedure, was replaced by another and the instrument continues to be in use at this dental practice. This means that instrument failure can be eliminated as a possible cause. Nevertheless, we have reviewed our production records. Lot nr. 03/05p identifies the instrument as a nopa device produced for (b)(4). Production started in (b)(4) 2004. Since then a total of (b)(4) instruments have been shipped. This is the first event involving one of these instruments. It has previously been suggested to ship these devices without the plastic tips. However, they are attached to prevent damage to sensitive mouth tissues and have to be removable for proper cleaning. In marketing the device, clients should possibly be alerted to the fact that the silicone tips have known to come off when treating children. It should then be at the dentist's discretion to decide whether or not to use them with young patients. Nopa knows of only one other incident with a competitive device where the tips were swallowed (see 8010704-2008-00001 involving a (b)(6) special needs youngster).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010704-2009-00001 |
| MDR Report Key | 2625794 |
| Report Source | 01,08 |
| Date Received | 2009-05-12 |
| Date Mfgr Received | 2009-04-14 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2012-06-25 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | WEILATTEN 7-9 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer Phone | 46294900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | KBN |
| Date Received | 2009-05-12 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH |
| Manufacturer Address | WEILATTEN 7-9 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-12 |