MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-18 for 3M(TM) ESPE(TM) RETRACTION CAPSULE manufactured by 3m Deutschland Gmbh.
[3059406]
On (b)(6) 2012 3m espe was informed about an adverse effect that occurred during the use of a 3m (tm) espe (tm) retraction capsule. During application the patient reacted with a tetany, attack of sweating, instable circulation, panic attacks and pain in the area of the sulcus. The symptoms started when the retraction pase was applied and stopped quickly after the removal of the paste. The event lasts for approximately 15 - 20 minutes. After this the patient fully recovered and there are no long-term effects.
Patient Sequence No: 1, Text Type: D, B5
[10496819]
Method, results and conclusions: until the date of this report the product wasn't returned to 3m (b)(4). As the symptoms vanished immediately after the removal of the paste, it can be concluded that the product really caused the symptoms. The type of reaction and the clinical history of the product do not indicate an allergic reaction. 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 | 9611385-2012-00008 |
| MDR Report Key | 2888496 |
| Report Source | 05 |
| Date Received | 2012-12-18 |
| Date of Report | 2012-11-21 |
| Date of Event | 2012-11-20 |
| Date Mfgr Received | 2012-08-07 |
| Date Added to Maude | 2012-12-31 |
| 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 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal | 82229 |
| 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 | 2012-12-18 |
| Lot Number | 493136 |
| 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 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-18 |