MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-11 for 3M (TM) ESPE (TM) RETRACTION CAPSULE 56944 manufactured by 3m Deutschland Gmbh.
[3373080]
On (b)(6) /2012 3m espe was informed about a adverse effect that occurred after the use of a 3m espe retraction capsule. About 4 hours after the use of the 3m espe retraction paste, the patient suffered from strong swelling on the left side of the face, which was also reddened. Additionally there was heat and tingling sensation all over the face. The area around the eye was dry and scaly. The symptoms vanished completely after five days and the patient is free of complaints. No further follow-up information is currently available to us.
Patient Sequence No: 1, Text Type: D, B5
[10350879]
Method, results and conclusions: until the date of this report the product wasn't returned to 3m (b)(4). The dentist discarded the capsules after the incident so the original lot-nr. Is not known to us. An interview with the dentist revealed, that she thinks that the symptoms could be caused by the retraction paste but she stated that it is more likely that the adverse event happened as a result of an intolerance to ultracain, a local anesthetic, which was also used during the treatment of the patient. 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 | 9611385-2013-00002 |
| MDR Report Key | 2919720 |
| Report Source | 05 |
| Date Received | 2013-01-11 |
| Date of Report | 2012-12-14 |
| Date of Event | 2012-10-24 |
| Date Mfgr Received | 2012-12-14 |
| Date Added to Maude | 2013-01-18 |
| 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 (TM) ESPE (TM) RETRACTION CAPSULE |
| Generic Name | RETRACTION CAPSULE |
| Product Code | MVL |
| Date Received | 2013-01-11 |
| Catalog Number | 56944 |
| 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 | 2013-01-11 |