MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for SMART TOOLS/SMART CUFFS AUTOMATIC PUMP manufactured by Unk.
[182514042]
Smart tools/smart cuffs continues to promote their non-listed automatic tourniquet pump on (b)(6) and (b)(6) and their website. They continually state their cuffs and pump are made in (b)(6). When searching for mfrs and contract mfrs for product category "kcy" there was only 2 fda listed companies: zimmer biomet (which is not in (b)(6)) and is a direct competitor; criterion tool and die, which does not make tourniquet cuffs or automatic devices. The only conclusion that can be reached is that the cuffs and automatic pump are not made in an fda registered facility. Lastly, this automatic pump has not been shown to have accurate limb occlusion pressure readings, potentially leading to life threatening complications. Would you please look into this? Unk, not believed to be an fda listed company. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093512 |
| MDR Report Key | 9786105 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-29 |
| Date Added to Maude | 2020-03-04 |
| 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 | 3 |
| Brand Name | SMART TOOLS/SMART CUFFS AUTOMATIC PUMP |
| Generic Name | TOURNIQUET, PNEUMATIC |
| Product Code | KCY |
| Date Received | 2020-03-03 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 2020-03-03 |