MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-16 for PALAPRESS VARIO, PINK 64707870 manufactured by Heraeus Kulzer Gmbh.
[33699442]
This occurred in (b)(6). (b)(4). This is a reportable malfunction according to 21 cfr 803. 50 (a) (2) which states that you must report to us no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Device has not been returned by customer. Device was not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[33699443]
This occurred in (b)(6). Conversation with lab: patient with known benzoyl peroxide allergy had burning and redness since 2013 under denture made with palapress vario.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610902-2015-00019 |
| MDR Report Key | 5303607 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-16 |
| Date of Report | 2015-11-20 |
| Date Facility Aware | 2015-12-09 |
| Date Mfgr Received | 2015-11-20 |
| Date Added to Maude | 2015-12-16 |
| 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 | MS. RITA ROGERS |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 466142517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALAPRESS VARIO, PINK |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2015-12-16 |
| Catalog Number | 64707870 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-16 |