MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-21 for SURGI-BRA * 46518-04LF manufactured by Cardinal Health.
[21417568]
Rn ordered xl surgical bra for patient. A box labeled surgi-bra was delivered to the unit. The rn opened the box in front of the patient and pulled out a bra that was blood stained. Rn removed the bra from the room, apologized to the patient and ordered another one. Night supervisor, materials management director and nurse manager notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2792049 |
| MDR Report Key | 2792049 |
| Date Received | 2012-09-21 |
| Date of Report | 2012-09-21 |
| Date of Event | 2012-07-10 |
| Report Date | 2012-09-21 |
| Date Reported to FDA | 2012-09-21 |
| Date Added to Maude | 2012-10-16 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGI-BRA |
| Generic Name | SURGICAL BRA |
| Product Code | HEF |
| Date Received | 2012-09-21 |
| Returned To Mfg | 2012-07-19 |
| Model Number | * |
| Catalog Number | 46518-04LF |
| Lot Number | UNK |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD-MPKB-2B MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-21 |