MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-05 for KENDALL DRY SKIN SCRUB TRAY 41523 manufactured by Covidien.
[79064882]
Patient Sequence No: 1, Text Type: N, H10
[79064883]
Contaminate in 'sterile' supply: kendall dry skin scrub tray opened to begin surgical prep. Approximately two inch single strand brown hair noted on plastic tray. New kendall dry skin scrub tray opened and proceeded with surgical prep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6685832 |
| MDR Report Key | 6685832 |
| Date Received | 2017-07-05 |
| Date of Report | 2017-06-16 |
| Date of Event | 2017-06-06 |
| Report Date | 2017-06-14 |
| Date Reported to FDA | 2017-06-14 |
| Date Reported to Mfgr | 2017-06-14 |
| Date Added to Maude | 2017-07-05 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL DRY SKIN SCRUB TRAY |
| Generic Name | SKIN PREP TRAY (KIT) |
| Product Code | OJU |
| Date Received | 2017-07-05 |
| Catalog Number | 41523 |
| Lot Number | 7059105764X |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-05 |