MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-30 for FLYTE 120V BATTERY CHARGER 0408655000 manufactured by Stryker Instruments-kalamazoo.
[181631656]
It was reported that at the user facility, the charger overheated and the rubber pads melted. There was no medical intervention and no adverse consequences with this event. As this event occurred during inspection at the user facility, there was no patient involvement and no delay to a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
[188145723]
Device evaluation: follow-up report submitted to document device evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[188145724]
It was reported that at the user facility, the charger overheated and the rubber pads melted. There was no medical intervention and no adverse consequences with this event. As this event occurred during inspection at the user facility, there was no patient involvement and no delay to a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00354 |
| MDR Report Key | 9647426 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-30 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-04-02 |
| Date Added to Maude | 2020-01-30 |
| 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 | MR. ZACH BAKER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLYTE 120V BATTERY CHARGER |
| Generic Name | ACCESSORY, SURGICAL APPAREL |
| Product Code | LYU |
| Date Received | 2020-01-30 |
| Returned To Mfg | 2020-02-21 |
| Model Number | 0408655000 |
| Catalog Number | 0408655000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |