MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-27 for LIFE REGULAR SET 61769 manufactured by Kerr Italia S.r.l..
[121991770]
It was reported by the complainant that life base was used as a pressure indication paste to identify areas of over extension on an acrylic denture complainant is aware that this is not the standard application. No patient information was provided in regards to weight, ethnicity, and race.
Patient Sequence No: 1, Text Type: N, H10
[121991771]
A complainant alleged that patient experienced throbbing and tightness particularly on the left anterior maxilla. Patient noticed swelling of the upper and lower lip as well as tongue. Patient also had a left ear ache. The pain extended to the infraorbital region and there was some mild periorbital swelling as well as watering of the eye. This continued to progress to a sore throat. Patient went to the hospital due to the continued symptoms. Patient was diagnosed with experiencing an allergic reaction, but no treatment was required. The swelling started to reduce, however there are two areas of ulceration present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020994-2018-00001 |
| MDR Report Key | 7916384 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2017-07-31 |
| Date Added to Maude | 2018-09-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PAULO CALLE |
| Manufacturer Street | 1717 W COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167752 |
| Manufacturer G1 | KERR ITALIA S.R.L. |
| Manufacturer Street | VIA PASSANTI 332 |
| Manufacturer City | SCAFATI, SA I-84018 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | I-84018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFE REGULAR SET |
| Generic Name | LIFE FAST SET, LIFE REGULAR SET |
| Product Code | EJK |
| Date Received | 2018-09-27 |
| Catalog Number | 61769 |
| Lot Number | 6456795 |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR ITALIA S.R.L. |
| Manufacturer Address | VIA PASSANTI 332 SCAFATI, (SA) 1-84018 IT 1-84018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-27 |