MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-12 for CUSTOM STERILE CARDIAC CATH PACK DYNJ 48731 manufactured by Medline.
[5873180]
Five reports of backing of adhesive on drape is folded onto itself allowing styrofoam sheet to stick to adhesive. This is part of a cardiac cath pack. This requires drape to be discarded and replaced before the case can begin. Dates of use: (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043121 |
| MDR Report Key | 4856240 |
| Date Received | 2015-06-12 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-06-11 |
| Date Added to Maude | 2015-06-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM STERILE CARDIAC CATH PACK |
| Generic Name | CUSTOM STERILE CARDIAC CATH PACK |
| Product Code | OES |
| Date Received | 2015-06-12 |
| Model Number | CARDIAC CATH PACK |
| Catalog Number | DYNJ 48731 |
| Lot Number | 15EB0217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-12 |