MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for CURAPLEX #477KLTSD4125 477-KLTSD4125 manufactured by Bound Tree Medical, Llc.
[181781686]
Curaplex supraglotic airway kit, king lts-d, size 2. 5, 25-35kg #477-kltsd4125 (lot #asm0021574) contains: (1) supraglotic airway, king lts-d size 2. 5 (1) syringe only, 10 oc luer lock (1) gastric tube, 16fr (1) packet of lubricating jelly. The manufacturer (ambu) of the king airway lts-d recommends an inflation volume of 30-40 cc for the device and the packaged product from the manufacturer comes with a syringe sized to support this volume. The 10 cc syringe found in the curaplex kit with the same king airway device could result in an under-inflated balloon if the user does not re-load the syringe with air 3-4 times. An under-inflated balloon could lead to device failure resulting in hypoxia and if untreated death. Curaplex product by samova hc. Llc's family of companies: bound tree medical llc. Cardic partners, inc. Emergency medical products, inc. & tri-anim health services inc. Distributor: (b)(4). Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093396 |
| MDR Report Key | 9774578 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-26 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CURAPLEX |
| Generic Name | AIRWAY, OROPHARYNGEAL, ANESTHESIIOLOGY |
| Product Code | CAE |
| Date Received | 2020-02-28 |
| Model Number | #477KLTSD4125 |
| Catalog Number | 477-KLTSD4125 |
| Lot Number | ASM0021574 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOUND TREE MEDICAL, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-02-28 |