MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-08 for 3M ESPE RETRACTION CAPSULE 56944 manufactured by 3m Deutschland Gmbh.
[15513079]
On (b)(6) 2012, 3m espe was informed about a adverse effect that occurred after the use of a 3m espe retraction capsule. During the use of the 3m espe retraction paste, the dentist inadvertently injected the paste into mucosal tissue as evidenced by a purplish color in the tissue. Upon follow-up a week later, it was learned that the affected tissue had necrosed and required intervention to slough it off thus removing the injected retraction paste. The dentist placed one stitch in the affected area. No further follow-up information is currently available on the pt status.
Patient Sequence No: 1, Text Type: D, B5
[15528356]
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 | 9611385-2013-00001 |
| MDR Report Key | 2917648 |
| Report Source | 05 |
| Date Received | 2013-01-08 |
| Date of Report | 2012-12-10 |
| Date of Event | 2012-12-10 |
| Date Mfgr Received | 2012-12-10 |
| Date Added to Maude | 2013-01-17 |
| 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 | 2013-01-08 |
| Catalog Number | 56944 |
| Lot Number | 482590 |
| Device Expiration Date | 2013-12-30 |
| 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 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-01-08 |