SPIRIT® HYDROCOLLOID ADHESIVE SHEATH Adverse Event — Injury (MDR 1018233-2020-02841)
SPIRIT® HYDROCOLLOID ADHESIVE SHEATH Adverse Event — Injury (MDR 1018233-2020-02841) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SPIRIT® HYDROCOLLOID ADHESIVE SHEATH; Generic name: MALE EXTERNAL CATHETER; Manufacturer: C.R. BARD, INC. (COVINGTON) -1018233.
| Device | SPIRIT® HYDROCOLLOID ADHESIVE SHEATH |
|---|---|
| Generic name | MALE EXTERNAL CATHETER |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Report number | 1018233-2020-02841 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | CONSUMER, DISTRIBUTOR, OTHER |
| Narrative | THE REPORTED EVENT COULD NOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿BIOCOMPATIBILITY¿ WITH A POTENTIAL ROOT CAUSE OF ¿MATERIALS NOT BIOCOMPATIBLE¿. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "PRECAUTION DO NOT USE IF ALLERGIC REACTION |
| Source | openFDA MAUDE (device adverse events) |
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