KIMBERLY- CLARK MICROCOOL SURGICAL GOWN Adverse Event — Malfunction (MDR 9680646-2008-00001)
KIMBERLY- CLARK MICROCOOL SURGICAL GOWN Adverse Event — Malfunction (MDR 9680646-2008-00001) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: KIMBERLY- CLARK MICROCOOL SURGICAL GOWN; Generic name: STERILE SURGICAL GOWN; Manufacturer: AVENT DE HONDURAS, S.A. DE C.V..
| Device | KIMBERLY- CLARK MICROCOOL SURGICAL GOWN |
|---|---|
| Generic name | STERILE SURGICAL GOWN |
| Manufacturer | AVENT DE HONDURAS, S.A. DE C.V. |
| Report number | 9680646-2008-00001 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Consumer, Health Professional |
| Narrative | IT WAS REPORTED TO THE MANUFACTURER BY SALES REPRESENTATIVE THAT DURING A SURGICAL PROCEDURE ON A PATIENT, A GOWN WORN BY THE SURGEON WAS SATURATED WITH A PATIENT'S BLOOD WHO WAS HEPATITIS C POSITIVE. IN A QUESTIONNAIRE FILLED OUT BY THE WEARER, IT WAS ALSO NOTED THAT BLOOD WAS VISIBLE ON THE WEARER'S SCRUBS AND ARMS AND CHEST WERE EXPOSED. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH AS A CONSE |
| Source | openFDA MAUDE (device adverse events) |
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