MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-13 for SD DEPTH ELECTRODE SD10R-SP05X-000 manufactured by Ad-tech Medical Instrument Corp..
[188247865]
Mdr 2183456-2020-00012 has been filed past the 30-day timeframe. Through the 2019 fda inspection, it was identified that while ad-tech was evaluating reportability for actual events in which death or serious injury had occurred, ad-tech had failed to submit events in which a malfunction was reported and could result in a serious injury if the event were to recur. As part of the investigation, a two (2) year retrospective review of complaints was performed to determine which complaints required submission of an mdr.
Patient Sequence No: 1, Text Type: N, H10
[188247866]
On october 25, 2017 ad-tech received a complaint of bent electrodes being found prior to clinical use. There was no report of patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2020-00012 |
| MDR Report Key | 9707897 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2017-10-25 |
| Device Manufacturer Date | 2016-01-06 |
| Date Added to Maude | 2020-02-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS NICOLE REMER |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK, WI |
| Manufacturer Country | US |
| Manufacturer Phone | 6341555301 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK, WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SD DEPTH ELECTRODE |
| Generic Name | DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2017-11-07 |
| Catalog Number | SD10R-SP05X-000 |
| Lot Number | 208140606 |
| Device Expiration Date | 2018-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 400 WEST OAKVIEW PARKWAY OAK CREEK, WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |