MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for LSRHKGYN manufactured by Leesar, Inc..
[120546428]
Operating room staff found issues with multiple leesar custom packs. Pn lsrhhminord- 1pk of 4x4 x-ray 16-ply left out (lot# 921181); pn lsrhhgynlac- 4x4 x-ray, 16-ply had 12 instead of 10 (lot# 876181); pn lsrhhgynlac- 4x4 x-ray, 16-ply had 8 instead of 10 (lot# 876181); pn lsrhhtohipb- has hair in the pack, pack is unopened (lot# 900181). Ln 3861000 incorrect raytex count; the pack had a total of two packs instead of one (lot#834181).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7884758 |
| MDR Report Key | 7884758 |
| Date Received | 2018-09-18 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-08-22 |
| Report Date | 2018-09-05 |
| Date Reported to FDA | 2018-09-05 |
| Date Reported to Mfgr | 2018-09-18 |
| Date Added to Maude | 2018-09-18 |
| 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 |
| 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 | LSRHKGYN |
| Generic Name | GYNECOLOGICAL LAPAROSCOPIC KIT |
| Product Code | OHD |
| Date Received | 2018-09-18 |
| Lot Number | 921181, 876181, 900181, 834181 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEESAR, INC. |
| Manufacturer Address | 11600 ADELMO LN FORT MYERS FL 33966 US 33966 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-18 |