MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-09 for 3M ESPE RETRACTION CAPSULE 56945 manufactured by 3m Deutschland Gmbh.
[3342447]
On (b)(6) 2013 3m espe was informed that a 3m espe retraction capsule broke during use and parts of the capsule got into the mouth of the patient. According to the dentist there was no health hazard and the parts of the capsule could be easily removed with the suction. The patient didn't notice the incident at all.
Patient Sequence No: 1, Text Type: D, B5
[10600177]
Method, results, conclusions - until the date of the report the product wasn't returned to 3m (b)(4). Such a case can occur if a dentist takes the capsule out of the blister and stores it for a time before using. Thus the consistency of the paste can change and higher pushing forces can be necessary to press the paste out of the capsule. This is clearly a handling error. The correct way of use is described in the instructions for use. According to the dentist he used the product in the correct way. The product was sent to 3m (b)(4) but hasn't arrived at the company yet. Further information will be obtained by examination of the concerned product or of a retained sample. 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 | 9611385-2013-00007 |
| MDR Report Key | 3061035 |
| Report Source | 05 |
| Date Received | 2013-04-09 |
| Date of Report | 2013-03-12 |
| Date of Event | 2013-02-25 |
| Date Mfgr Received | 2013-03-12 |
| Date Added to Maude | 2013-06-06 |
| 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 | ESPEPLATZ |
| 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 ESPE RETRACTION CAPSULE |
| Generic Name | RETRACTION CAPSULE |
| Product Code | MVL |
| Date Received | 2013-04-09 |
| Catalog Number | 56945 |
| Lot Number | 486810 |
| 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. Required No Informationntervention | 2013-04-09 |