MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for JOBST KN SMAL 20-30 MMGH manufactured by Unk.
[132796400]
The facility received ultrasheer/ kne mis med. However, the order should have been for jobst kn smal 20-30 mmhg. Investigation results: after review of the above issues, the following was determined: type of medication error: incorrect product; was the medication administered to the resident? : no; area where error occurred: data entry; medication(s) product(s) involved: ultrasheer/kne mis med vs jobst kn small 20-30mmhg, order error potential: low root cause; the name of the product was clearly written. In accordance with policy and procedure, the data entry tech should have entered the correct product on the order. In accordance with the policy and procedure, the pharmacist should have verified the correct product and deviated from the established policy and procedure by approving the order as correct. The data entry technician and pharmacist were not in present time with the script. (b)(6); access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082943 |
| MDR Report Key | 8228494 |
| Date Received | 2019-01-07 |
| Date of Report | 2018-01-07 |
| Date Added to Maude | 2019-01-08 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | JOBST KN SMAL 20-30 MMGH |
| Generic Name | STOCKING, MEDICAL SUPPORT |
| Product Code | FQL |
| Date Received | 2019-01-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | ULTRASHEER / KNE MIS MED |
| Generic Name | STOCKING, MEDICAL SUPPORT |
| Product Code | FQL |
| Date Received | 2019-01-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-07 |