MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-10 for MEDLINE MDTPG5RTSDEMZ manufactured by Medline Industries, Inc..
[54710872]
Entered resident's room to give meds and saw he wasn't in bed, found him sitting on floor with his head down and noticed his gown strings in the back were caught on the side rail. I could tell he was deceased, i felt no pulse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5948844 |
| MDR Report Key | 5948844 |
| Date Received | 2016-09-10 |
| Date of Report | 2016-09-09 |
| Date of Event | 2016-08-28 |
| Date Facility Aware | 2016-08-28 |
| Report Date | 2016-09-09 |
| Date Reported to FDA | 2016-09-09 |
| Date Reported to Mfgr | 2016-09-13 |
| Date Added to Maude | 2016-09-14 |
| 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 | 0 |
| 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 |
| Generic Name | PATIENT GOWN |
| Product Code | FME |
| Date Received | 2016-09-10 |
| Catalog Number | MDTPG5RTSDEMZ |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-09-10 |