AVITENE WEB SHEETS Adverse Event — Malfunction (MDR 1213643-2020-04114)
AVITENE WEB SHEETS Adverse Event — Malfunction (MDR 1213643-2020-04114) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AVITENE WEB SHEETS; Generic name: AGENT, ABSORBABLE, HEMOSTATIC, COLLAGEN BASED; Manufacturer: DAVOL INC., SUB. C.R. BARD, INC..
| Device | AVITENE WEB SHEETS |
|---|---|
| Generic name | AGENT, ABSORBABLE, HEMOSTATIC, COLLAGEN BASED |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Report number | 1213643-2020-04114 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, FOREIGN, USER FACI |
| Narrative | THE SUBJECT PRODUCT HAS BEEN RECEIVED; HOWEVER, DUE TO THE CV-19 CLOSURE IMPACT OF THE EVALUATION LAB, THE EVALUATION OF THE PHYSICAL SAMPLE HAS BEEN DELAYED. A PHOTO OF THE SUBJECT PRODUCT WAS PROVIDED AND CONFIRMS A THREAD RESEMBLING A ¿FIBER¿ PRESENTED IN THE PACKAGE WITH ONE END CAUGHT WITHIN THE LID TO TRAY PACKAGE SEAL. THE PACKAGING OF THE SUBJECT PRODUCT IN THE PROVIDED PHOTO APPEARS TO BE |
| Source | openFDA MAUDE (device adverse events) |
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