MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for CARDINAL HEALTH SAN12HPHMB manufactured by Cardinal Health 200, Llc.
[143700958]
The adhesive that adheres the pacemaker drape to the patient was separating from the drape we have had 4 reports related to this. All events were of the same model # and lot#.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8568425 |
| MDR Report Key | 8568425 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-04-04 |
| Report Date | 2019-04-30 |
| Date Reported to FDA | 2019-04-30 |
| Date Reported to Mfgr | 2019-05-01 |
| Date Added to Maude | 2019-05-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CARDINAL HEALTH |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2019-05-01 |
| Model Number | SAN12HPHMB |
| Catalog Number | SAN12HPHMB |
| Lot Number | 528087 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |