MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-05 for SET UP PACK DYNJ31686 manufactured by Medline Industries, Inc..
[85091260]
Patient Sequence No: 1, Text Type: N, H10
[85091261]
There was a film on the product along with yellow staining.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6841781 |
| MDR Report Key | 6841781 |
| Date Received | 2017-09-05 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-07-24 |
| Report Date | 2017-08-28 |
| Date Reported to FDA | 2017-08-28 |
| Date Reported to Mfgr | 2017-08-28 |
| Date Added to Maude | 2017-09-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | SET UP PACK |
| Generic Name | LAPAROSCOPY KIT |
| Product Code | FDE |
| Date Received | 2017-09-05 |
| Model Number | DYNJ31686 |
| Catalog Number | DYNJ31686 |
| Lot Number | 16WB9369 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1204 TOWNLINE RD 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-05 |