MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for MEDLINE BLUE OR TOWELS MDT2168206XR manufactured by Medline Industries, Inc..
[123874753]
Sterile packaged blue operating room towels were opened and found to have sand-like substance inside them. Product was removed from pt care area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080535 |
| MDR Report Key | 7964898 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-10-01 |
| Date Added to Maude | 2018-10-15 |
| 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 | 0 |
| Brand Name | MEDLINE BLUE OR TOWELS |
| Generic Name | FIBER, MEDICAL, ABSORBENT |
| Product Code | FRL |
| Date Received | 2018-10-12 |
| Catalog Number | MDT2168206XR |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-10-12 |