MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2015-01-28 for PALAPRESS 500G 64707805 manufactured by Heraeus Kulzer Gmbh.
[5403838]
This incident occurred in (b)(6). Report was received of an allergic reaction in a patient after a prosthetic treatment with palapress. The practitioner did not give detailed information concerning the symptoms. Only the information was provided that an allergic reaction occurred. In the meantime, the patient received another prosthesis. I could not get the patient's name, staff suggested that her boss would not allow to give this information. Because of the anonymity no patient number was given. Contact person at the dental surgery is (b)(6). This is reportable according to 21 cfr 803. There is an allegation of serious injury as defined in part 803. 3. The patient involved is investigating a potential allergic reaction. No accusation or proof has been given that this device caused or contributed to the patients symptoms. Out of an abundance of caution we will report this incident. Report to fda due to product being substantially equivalent to product available for purchase in north america.
Patient Sequence No: 1, Text Type: D, B5
[12783363]
(b)(4). 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. Method/results/conclusion - device has not been returned by customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610902-2015-00002 |
| MDR Report Key | 4458852 |
| Report Source | 01 |
| Date Received | 2015-01-28 |
| Date of Report | 2015-01-07 |
| Date Facility Aware | 2015-01-07 |
| Date Mfgr Received | 2015-01-07 |
| Date Added to Maude | 2015-01-28 |
| 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, LLC |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALAPRESS 500G |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2015-01-28 |
| Catalog Number | 64707805 |
| Operator | OTHER |
| 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 | 2015-01-28 |