MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-04 for KIMBERLY-CLARK STERILE BASIC PACK manufactured by Halyard Health, Inc..
[34906529]
Patient Sequence No: 1, Text Type: N, H10
[34906530]
Pack was opened and on a paper bag, hair was found stuck. Field was broken down and set over with sterile supplies.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5340103 |
| MDR Report Key | 5340103 |
| Date Received | 2016-01-04 |
| Date of Report | 2015-12-18 |
| Date of Event | 2015-12-15 |
| Report Date | 2015-12-18 |
| Date Reported to FDA | 2015-12-18 |
| Date Reported to Mfgr | 2015-12-18 |
| Date Added to Maude | 2016-01-04 |
| 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 | 0 |
| 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 | KIMBERLY-CLARK STERILE BASIC PACK |
| Generic Name | SURGICAL KIT/TRAY |
| Product Code | LRP |
| Date Received | 2016-01-04 |
| Lot Number | AC5194D |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. |
| Manufacturer Address | 5405 WINDWARD PKWY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-04 |