MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-09 for VENUS TEMP 2 66049182 manufactured by Heraeus Kulzer Gmbh.
[15810631]
Dds reported to hk (b)(4) - adverse reaction to venus provisional material. Female patient had temps placed two weeks ago, reportedly had swelling lips which dds characterized as angioneurotic edema of the lip. (b)(4) called to get more information and spoke with dds. The patient works in a medical office and medicated with benadryl and rx prednisone. She did not inform dds of her adverse reaction until yesterday ((b)(6) 2014). Patient still has a swollen lip. Dds stated patient had no known allergies, that he had used venus temp ii. Asked permission for doug to make a follow-up call to ensure this was handled completely and properly. Dds called in response to older inquiry for his phone number, was transferred over to (b)(4). Dds stated that the patient is in her (b)(6). The preps were 6-11 and the upper lip is the only lip affected. He said that she called him the day after and he didn't report it because he didn't think it would last more than a day or 2. He has not done any other crowns on this patient, so he has not experienced this with her before. He said he had to go before i could get a shade and lot number. I did ask if we could follow up in a week to see how the patient is progressing. He said we could. This incident is reportable according to 21 cfr 803. The fda defines this as a serious injury (21 cfr sec. 803. 3) as the patient reported having an adverse reaction.
Patient Sequence No: 1, Text Type: D, B5
[15953781]
(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: because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined. This is classified as a near incident in that the timely intervention of medical staff will prevent any lasting damage or impairment to the patient's physical state. Evaluation summary: because said product has not been returned, there is no compelling proof of causation of any adverse effects. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005665377-2014-00007 |
| MDR Report Key | 4071178 |
| Report Source | 05 |
| Date Received | 2014-09-09 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-07-29 |
| Date Facility Aware | 2014-08-12 |
| Report Date | 2014-09-02 |
| Date Reported to Mfgr | 2014-09-02 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-09-09 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| 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 | GRUNER WEG 11 |
| Manufacturer City | HANAU, D-63450 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-63450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENUS TEMP 2 |
| Generic Name | CROWN AND BRIDGE, TEMPORARY RESIN |
| Product Code | EBG |
| Date Received | 2014-09-09 |
| Catalog Number | 66049182 |
| ID Number | A2 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | GRUNER WEG 11 HANAU, D-63450 GM D-63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-09 |