MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-06 for PALAPRESS VARIO manufactured by Heraeus Kulzer Gmbh.
[3814479]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11286378]
As allowed by exemption # (b)(4) (the importer) is submitting the report on behalf of heraeus (b)(4) (the manufacturer). 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. The material used was of mixed lots due to the fact that the dental lab purchases large containers (10 kg) and reduce this amount in the lab by re-filling continuously smaller containers in a kind of solera-technique. The directions for use states, "product contains monomers (e. G. Methacrylates) which may cause skin allergies, especially with sensitive patients. For patients with a resin allergy history or when allergic reactions are observed, the product is contraindicated. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610902-2013-00087 |
| MDR Report Key | 3342100 |
| Report Source | 05 |
| Date Received | 2013-09-06 |
| Date Mfgr Received | 2013-08-08 |
| Date Added to Maude | 2013-09-12 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AUDI BOGUCKI, RDH |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH & CO. KG |
| Manufacturer Street | PHILIPP-REIS-STRASSE 8/13 |
| Manufacturer City | WEHRHEIM D-61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-61273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALAPRESS VARIO |
| Generic Name | EBI RESIN, DENTURE, RELINING, REPAIRING |
| Product Code | EBI |
| Date Received | 2013-09-06 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | WEHRHEIM GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-06 |