SUPER SHEATH Adverse Event — Injury (MDR 9612126-2020-00008)
SUPER SHEATH Adverse Event — Injury (MDR 9612126-2020-00008) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SUPER SHEATH; Generic name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION; Manufacturer: TOGO MEDIKIT CO. LTD..
| Device | SUPER SHEATH |
|---|---|
| Generic name | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Manufacturer | TOGO MEDIKIT CO. LTD. |
| Report number | 9612126-2020-00008 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, FOREIGN |
| Narrative | THE ACTUAL ITEM OF THIS EVENT WAS NOT RETURNED. WHEN A REPRODUCIBILITY TEST WAS PERFORMED USING THE SAME TYPE OF PRODUCT HAVING THE SAME SPECIFICATIONS AS THE PRODUCT IN QUESTION, IT WAS CONFIRMED THAT THE TENSILE STRENGTH SATISFIED THE STANDARD. IN ADDITION, A PHOTO OF THE ACTUAL PRODUCT WAS PROVIDED BY A MEDICAL INSTITUTION, AND AS A RESULT OF AN ENLARGED INVESTIGATION OF THE FRACTURED PART IN T |
| Source | openFDA MAUDE (device adverse events) |
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