MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for MEDLINE TOTAL KNEE PACK DYNJ42553C manufactured by Medline Industries. Inc..
[176622375]
Hole in major knee pack. Upon opening knee pack for sterile field, a hole was seen, pack was removed from the room, and a new opened. Patient was not in the room and unsterile pack did not reach the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092489 |
| MDR Report Key | 9631846 |
| Date Received | 2020-01-24 |
| Date Added to Maude | 2020-01-27 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | MEDLINE TOTAL KNEE PACK |
| Generic Name | ORTHOPEDIC TRAY |
| Product Code | OJH |
| Date Received | 2020-01-24 |
| Catalog Number | DYNJ42553C |
| Lot Number | 19VBH452 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES. INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |