MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-06 for MDTPG5RTSDEMZ manufactured by Medline Industries Inc..
[56760201]
Per director of nursing (don) at facility who stated on (b)(6) nursing staff found a patient deceased with patient gown strings caught in side rail of bed. Per don patient was resident of the nursing home due to multiple cardiac and respiratory issues. Patient was oxygen dependent and needed assistance to get in and out of bed. Patient would not get out of bed without assistance due to weakness. Patient used a walker on a daily basis when out of bed. Patient was found sitting on floor; his back was leaning against his bed with his chin resting on his chest. The neck of the gown was caught around the raised edge of the siderail end cap. Gown strings were tied, ends of strings were not entangled on any part of the siderail or bed. Bed was in it's lowest position; head of bed elevated to an unknown degree, with both upper side rails in the up position. Patient call button was within reach, no bed alarm was on. Patient bed was not manufactured by medline. The age and overall condition of the bed and siderail is unknown. A root cause for this incident has not been determined. Due to the reported death and in an abundance of caution this medwatch is being filed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[56760202]
Patient found on floor with gown attached to bedrail and pronounced dead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00100 |
| MDR Report Key | 6004595 |
| Date Received | 2016-10-06 |
| Date of Report | 2016-10-06 |
| Date of Event | 2016-08-28 |
| Date Mfgr Received | 2016-09-12 |
| Date Added to Maude | 2016-10-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | GOWN, PATIENT |
| Product Code | FYB |
| Date Received | 2016-10-06 |
| Catalog Number | MDTPG5RTSDEMZ |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-10-06 |