MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for MEDICHOICE WOD3003 manufactured by Dalian Goodwood Medical Care Ltd..
[50068038]
(b)(4), the initial importer and private-label distributor of medichoice tongue depressor, wod3003, lot: 1512dg09b, received a product problem report from end user, (b)(6), on (b)(6) 2016. The end user reported that a defective tongue depressor was used on a patient. An anesthesiologist used the tongue depressor while intubating a patient. The anesthesiologist did not remember seeing that the tongue depressor was defective until after it was used. Therefore, the health professional was uncertain whether a piece of the depressor was detached during intubation or whether it was previously missing a piece. An emergency laryngoscopy was performed to make sure that there were no pieces of the depressor in the patient's airway. The procedure confirmed that none of the tongue depressor was found to have detached in the patient's airway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003753847-2016-00002 |
| MDR Report Key | 5803002 |
| Date Received | 2016-07-19 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-05-24 |
| Date Facility Aware | 2016-05-25 |
| Report Date | 2016-07-18 |
| Date Reported to FDA | 2016-07-18 |
| Date Reported to Mfgr | 2016-05-27 |
| Date Added to Maude | 2016-07-19 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | MEDICHOICE |
| Generic Name | TONGUE DEPRESSOR, 6", WOOD SHAFT |
| Product Code | FMA |
| Date Received | 2016-07-19 |
| Model Number | WOD3003 |
| Catalog Number | WOD3003 |
| Lot Number | 1512DG09B |
| Device Expiration Date | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DALIAN GOODWOOD MEDICAL CARE LTD. |
| Manufacturer Address | 3-91 JIULICUN YONGZHENG STREET JINZHOU DISTRICT DALIAN LIAONING 116100 CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-19 |