MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-16 for NI 622258 manufactured by Medline Industries = Phs Packs.
[5872309]
Phs total knee catalog 622258, lot 1185509 rev 15. Contaminants include: a) ink transfer from time out towel. B) red thread in disposable towel. Same reporter in mw5043161- mw5043178.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043171 |
| MDR Report Key | 4859416 |
| Date Received | 2015-06-16 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-01 |
| Date Added to Maude | 2015-06-23 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NI |
| Generic Name | MODULE OR PACK = TOTAL KNEE |
| Product Code | LRP |
| Date Received | 2015-06-16 |
| Catalog Number | 622258 |
| Lot Number | 1185509 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES = PHS PACKS |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-16 |