MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-13 for LAMINECTOMY PACK DYNJ04557R manufactured by Medline Industries, Inc..
[166199197]
Toe/finger nail found in lap sponge of laminectomy pack-pack b. In order to ready new set of supplies, two hour delay in surgery start time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9314594 |
| MDR Report Key | 9314594 |
| Date Received | 2019-11-13 |
| Date of Report | 2019-10-29 |
| Date of Event | 2019-10-10 |
| Report Date | 2019-10-30 |
| Date Reported to FDA | 2019-10-30 |
| Date Reported to Mfgr | 2019-11-13 |
| Date Added to Maude | 2019-11-13 |
| 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 | LAMINECTOMY PACK |
| Generic Name | ORTHOPEDIC TRAY |
| Product Code | OJH |
| Date Received | 2019-11-13 |
| Model Number | DYNJ04557R |
| Catalog Number | DYNJ04557R |
| Lot Number | 19HKB745 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-11-13 |