MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-08 for CORONARY CUSTOM PACK ORHS031-18 manufactured by Avid Medical, Inc. A Medical Action Ind. Company.
[76972057]
Patient Sequence No: 1, Text Type: N, H10
[76972058]
Upon opening our ep coronary pack a brown/black speck was noticed on our fluid bowl. We deemed it contaminated and opened a new pack. No injury to the patient occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6621455 |
| MDR Report Key | 6621455 |
| Date Received | 2017-06-08 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-04-18 |
| Report Date | 2017-05-11 |
| Date Reported to FDA | 2017-05-11 |
| Date Reported to Mfgr | 2017-05-11 |
| Date Added to Maude | 2017-06-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORONARY CUSTOM PACK |
| Generic Name | CARDIOVASCULAR PROCEDURE KIT |
| Product Code | OES |
| Date Received | 2017-06-08 |
| Catalog Number | ORHS031-18 |
| Lot Number | 1223238 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY |
| Manufacturer Address | 9000 WESTMONT DR. STONEHOUSE COMMERCE PARK TOANO VA 23168 US 23168 |
| Brand Name | CORONARY CUSTOM PACK |
| Generic Name | CARDIOVASCULAR PROCEDURE KIT |
| Product Code | OEZ |
| Date Received | 2017-06-08 |
| Catalog Number | ORHS031-18 |
| Lot Number | 1223238 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY |
| Manufacturer Address | 9000 WESTMONT DR. STONEHOUSE COMMERCE PARK TOANO VA 23168 US 23168 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-08 |