MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for MINOR ORTHO PACK DYNJ47949C manufactured by Medline Industries, Inc..
[109442636]
Patient Sequence No: 1, Text Type: N, H10
[109442637]
Elderly female sustained fall at home resulting in a trimalleolar fracture due to dislocation requiring ankle open reduction internal fixation. When preparing the operating room, a minor ortho procedure pack was opened and a hair was found with the raytec sponges by the scrub tech. The back table was broken down and a new minor ortho pack was opened prior to the patient arriving into the operating room. No patient harm, no delay to procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7550304 |
| MDR Report Key | 7550304 |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-05-11 |
| Report Date | 2018-05-14 |
| Date Reported to FDA | 2018-05-14 |
| Date Reported to Mfgr | 2018-05-14 |
| Date Added to Maude | 2018-05-29 |
| 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 |
| 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 | MINOR ORTHO PACK |
| Generic Name | ORTHOPEDIC TRAY |
| Product Code | LRP |
| Date Received | 2018-05-29 |
| Model Number | DYNJ47949C |
| Lot Number | 180B0685 |
| ID Number | 0110889942650248 |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-29 |