MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-13 for MEDLINE INDUSTRIES, INC. manufactured by Medline Industries, Inc..
[85942303]
Patient Sequence No: 1, Text Type: N, H10
[85942304]
Upon opening for a case the scrub tech found a dead fly on one of the laps in a c-section pack. Per site reporter: medline initiated a quality review investigation and supplied us with replacement product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6861422 |
| MDR Report Key | 6861422 |
| Date Received | 2017-09-13 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-05-04 |
| Report Date | 2017-08-11 |
| Date Reported to FDA | 2017-08-11 |
| Date Reported to Mfgr | 2017-08-11 |
| Date Added to Maude | 2017-09-13 |
| 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 |
| 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 | CESAREAN SECTION TRAY |
| Product Code | OHM |
| Date Received | 2017-09-13 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 17AB7412 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1170 S NORTHPOINT BLVD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-13 |