MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for MEDLINE INDUSTRIES, INC. DYNJ04557R manufactured by Medline Industries, Inc..
[173461759]
Hair found on lap sponge in laminectomy pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9543056 |
| MDR Report Key | 9543056 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-06-07 |
| Report Date | 2019-12-17 |
| Date Reported to FDA | 2019-12-17 |
| Date Reported to Mfgr | 2020-01-03 |
| Date Added to Maude | 2020-01-03 |
| 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 | RISK MANAGER |
| 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 | MEDLINE INDUSTRIES, INC. |
| Generic Name | ORTHOPEDIC TRAY |
| Product Code | OJH |
| Date Received | 2020-01-03 |
| Model Number | DYNJ04557R |
| Catalog Number | DYNJ04557R |
| Lot Number | 19GKB556 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |