MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-11-21 for PALAPRESS 64710513 manufactured by Heraeus Kulzer Gmbh.
[5229925]
This incident occurred in (b)(6) and is being investigated as a plastic allergy. Female patient had slight discomfort: white edge of upper lip. In interviewing the denture lab used, the lab tech could not determine which product had been used: palaxpress or palapress. Patient was confirmed to have allergies to benzoyl peroxide, balsam of (b)(6), new prosthesis is made of valplast. Although we cannot determine which product, palaxpress or palapress (b)(4), if either, caused or contributed to the patient's adverse reaction, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
[12495187]
(b)(4). Although we cannot determine which product, palaxpress or palapress (b)(4), if either, caused or contributed to the patient's adverse reaction, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. (b)(4). Since the actual device has not been returned, the cause of the patient's adverse reaction could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610902-2014-00053 |
| MDR Report Key | 4270275 |
| Report Source | 01,05 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-11-17 |
| Date Mfgr Received | 2014-11-17 |
| Date Added to Maude | 2014-11-21 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 GMBH |
| 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 |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2014-11-21 |
| Catalog Number | 64710513 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-11-21 |