MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-11-24 for NORMED GEMERIC TRAUMA UNK manufactured by Normed Medizin-technik Gmbh.
[5081066]
It was reported that an easy explant bit (drill bit) showed corrosion. As the occurrence date of the event is unk, the mfr's awareness date was taken as occurrence date.
Patient Sequence No: 1, Text Type: D, B5
[12584689]
The mfr did not receive devices, x-rays, or other source documents for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. A cause for this specific event cannot be ascertained from the info provided. Once more detailed info becomes available, a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613350-2014-04135 |
| MDR Report Key | 4290386 |
| Report Source | 01,08 |
| Date Received | 2014-11-24 |
| Date of Report | 2014-01-22 |
| Date of Event | 2014-01-22 |
| Date Mfgr Received | 2014-01-22 |
| Date Added to Maude | 2014-12-04 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5742676 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NORMED GEMERIC TRAUMA |
| Generic Name | UNKNOWN |
| Product Code | HTT |
| Date Received | 2014-11-24 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORMED MEDIZIN-TECHNIK GMBH |
| Manufacturer Address | ULRICHSTRASSE 7 TUTTLINGEN SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-24 |