MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-14 for 3M (TM) ESPE (TM) RETRACTION CAPSULE 56944 manufactured by 3m Deutschland Gmbh.
[3554390]
On (b)(4) 2013 3m (b)(4) was informed about a adverse effect that occurred after the use of a 3m (tm) espe (tm) retraction capsule. During the use of the 3m (tm) espe (tm) retraction paste, the patient suffered from nausea, dizziness, and circulatory instability. The symptoms lasted for about one day and then vanished completely. Currently, the patient is free of complaints. In a follow-up interview the dentist stated, that the patient had episodes of nausea, dizziness, and circulatory already before the treatment, but this time the symptoms could be provoked by the treatment with the retraction paste.
Patient Sequence No: 1, Text Type: D, B5
[10752008]
Method, results and conclusions: the product wasn't returned to 3m (b)(4). The dentist discarded the capsules after the incident, but informed us about the original lot-nr. An examination of a reserve sample of the same lot showed that there was no deviation in the specification of the device. In a follow-up interview the dentist stated, that the patient had episodes of nausea, dizziness, and circulatory already before the treatment, but this time the symptoms could be provoked by the treatment with the retraction paste. It is highly probably that not the material itself caused the symptoms but a state of anxiety during the treatment as the usage of the retraction paste can be unpleasant. This product has been assessed for biocompatibility and has been found to be safe for its intended use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611385-2012-00009 |
| MDR Report Key | 3181385 |
| Report Source | 05 |
| Date Received | 2013-06-14 |
| Date of Report | 2013-05-15 |
| Date of Event | 2013-04-30 |
| Date Mfgr Received | 2013-05-15 |
| Date Added to Maude | 2013-06-24 |
| 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, BAVARIA |
| Manufacturer Country | GM |
| Manufacturer Phone | 1527001327 |
| 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 (TM) ESPE (TM) RETRACTION CAPSULE |
| Generic Name | RETRACTION CAPSULE |
| Product Code | MVL |
| Date Received | 2013-06-14 |
| Catalog Number | 56944 |
| Lot Number | 494971 |
| Device Expiration Date | 2014-04-30 |
| 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 | SEEFELD, BAVARIA GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-14 |