MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for HALYARD 79529 manufactured by Halyard.
[145942909]
Blood and fluid leaked through c-section drape onto patient. Event was discovered post procedure once the drape was removed from the patient. The drape was discarded so the lot number for the drape used in the procedure was not reported. Patient was given antibiotics post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014527682-2019-00001 |
| MDR Report Key | 8629014 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-05-07 |
| Date Mfgr Received | 2019-05-07 |
| Date Added to Maude | 2019-05-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS CHEYENNE STEWART |
| Manufacturer Street | 3000 EAST SAWYER ROAD |
| Manufacturer City | REPUBLIC MO 65738 |
| Manufacturer Country | US |
| Manufacturer Postal | 65738 |
| Manufacturer Phone | 4177303937 |
| Manufacturer G1 | RESOURCE OPTIMIZATION & INNOVATION, L.L.C. |
| Manufacturer Street | 3000 EAST SAWYER ROAD |
| Manufacturer City | REPUBLIC MO 65738 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 65738 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HALYARD |
| Generic Name | C-SECTION FLUID COLLECTION DRAPE II WITH INCISE |
| Product Code | OHM |
| Date Received | 2019-05-21 |
| Model Number | 79529 |
| Catalog Number | 79529 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-21 |