MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-07-16 for CAVIT W 44123 manufactured by 3m Espe Ag.
[879888]
It was reported to 3m espe by an oral surgeon that a female patient experienced dizziness and nausea several minutes after completion of a dental treatment in which 3m espe cavit w was used. This patient receives her dental care under general anesthesia because of pre-existing allergies. As part of the medical treatment provided to her after the symptoms began, the cavit w was removed and a physiological saline infusion was administered by the attending anesthesiologist. The reported symptoms did not improve even after 30 minutes, so the patient was admitted to the hospital where she was treated for three days. Details on the hospital treatment provided were not made available to 3m espe, but it was reported that the patient has recovered.
Patient Sequence No: 1, Text Type: D, B5
[8083875]
Device was not returned to 3m, therefore, no evaluation was conducted. No results or conclusions can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611385-2008-00006 |
| MDR Report Key | 1079095 |
| Report Source | 05 |
| Date Received | 2008-07-16 |
| Date of Report | 2008-06-19 |
| Date of Event | 2008-04-01 |
| Date Mfgr Received | 2008-06-19 |
| Date Added to Maude | 2008-10-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. DESI SOEGIARTO |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal | 82229 |
| Manufacturer Phone | 1527001169 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVIT W |
| Generic Name | TEMPORARY FILLING MATERIAL |
| Product Code | EBD |
| Date Received | 2008-07-16 |
| Catalog Number | 44123 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1203726 |
| Manufacturer | 3M ESPE AG |
| Manufacturer Address | ESPE PLATZ SEEFELD GM 82229 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-07-16 |