MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-23 for 3M ESPE RETRACTION CAPSULE manufactured by 3m Deutschland Gmbh.
[15507729]
On (b)(6) 2012, 3m espe was informed about a potentially adverse effect that occurred during the use of a 3m espe retraction capsule. During application the capsule split and parts of it get into the pt's throat. The parts could be removed with a cotton pliers without complications and no adverse health effect occurred. Additional info is unavailable to 3m espe at this time point.
Patient Sequence No: 1, Text Type: D, B5
[15529786]
Method, results and conclusions: until the date of this report the product wasn't returned to 3m (b)(4). The dentist planed to send it this week. After receipt of the medical device it will be analyzed. The dentist indicated that it was difficult to extrude the material from the capsule, requiring more force than normal. That could be an evidence for a defective primary packaging or a deviation in the consistency of the retraction paste. More info will be available after the analysis of the returned samples. 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 | 9611385-2012-00005 |
| MDR Report Key | 2717445 |
| Report Source | 05 |
| Date Received | 2012-08-23 |
| Date of Report | 2012-08-07 |
| Date of Event | 2012-08-07 |
| Date Mfgr Received | 2012-08-07 |
| Date Added to Maude | 2012-08-29 |
| 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 ESPE RETRACTION CAPSULE |
| Generic Name | RETRACTION CAPSULE |
| Product Code | MVL |
| Date Received | 2012-08-23 |
| Lot Number | 476860 |
| Device Expiration Date | 2013-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-08-23 |