MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-18 for KERR 26755 manufactured by Kerr.
[108724406]
No information on race was provided. Product is not available for return and no lot number was provided, therefore no evaluation could be conducted. Patient identified that his redness has lessened after taking prescription medication. ]
Patient Sequence No: 1, Text Type: N, H10
[108724407]
An alleged complaint was reported that a patient got integra alginate impression running down his face, arm, and hand. He reported redness and dry mouth. Required prescription medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1815757-2018-00001 |
| MDR Report Key | 7528161 |
| Date Received | 2018-05-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2018-04-18 |
| Date Added to Maude | 2018-05-18 |
| 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 |
| 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 AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167752 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 28200 WICK ROAD |
| Manufacturer City | ROMULUS CA 48174 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48174 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KERR |
| Generic Name | ALGINATE |
| Product Code | ELW |
| Date Received | 2018-05-18 |
| Catalog Number | 26755 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR |
| Manufacturer Address | 28200 WICK ROAD ROMULUS MI 48174 US 48174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-18 |