MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-01 for FLEXITIME CORRECT FLOW (DEVICE 2) manufactured by Heraeus Kulzer Gmbh.
[3713184]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11056069]
As allowed by exemption (b)(4) (the importer) is submitting the report on behalf of heraeus (b)(4) (the mfr). Although we have not established that the device caused or contributed to the event, we are reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Conclusion: the labelling warns against ingestion and issues involved with swallowing. The directions for use states, "do not swallow and ingest. If health problems arise after swallowing impression metrial, seek medical attention immediately. Intestinal blockage may arise in rare cases. " due to the aforementioned reason, capa measures are not recommended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681707-2013-00007 |
| MDR Report Key | 3292108 |
| Report Source | 05 |
| Date Received | 2013-08-01 |
| Date Mfgr Received | 2013-07-08 |
| Date Added to Maude | 2013-08-19 |
| 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 |
| Manufacturer Street | ALTE HEERSTRASSW GEB B802 |
| Manufacturer City | DORMAGEN 41538 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 41538 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXITIME CORRECT FLOW (DEVICE 2) |
| Generic Name | ELM MATERIAL, IMPRESSION |
| Product Code | ELM |
| Date Received | 2013-08-01 |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | DORMAGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-01 |