MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-11 for MEDICHOICE? WOD1004 manufactured by Dalian Goodwood Medical Care Ltd.
[33287845]
(b)(4) the initial importer and private-label distributor of the medichoice? Cotton-tipped applicator, received an adverse event and product problem report from an end user at a user facility. The end user reported that the cotton tip fell off of the applicator and into the incision. The cotton-tip was discovered to be missing after the incision was closed. The incision had to be opened to remove the cotton.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003753847-2015-00001 |
| MDR Report Key | 5289713 |
| Date Received | 2015-12-11 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-11-18 |
| Date Facility Aware | 2015-11-19 |
| Report Date | 2015-12-11 |
| Date Reported to FDA | 2015-12-11 |
| Date Reported to Mfgr | 2015-11-25 |
| Date Added to Maude | 2015-12-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | STERILE COTTON TIP APPLICATOR |
| Product Code | KXG |
| Date Received | 2015-12-11 |
| Model Number | WOD1004 |
| Catalog Number | WOD1004 |
| Lot Number | 1501DG04B |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DALIAN GOODWOOD MEDICAL CARE LTD |
| Manufacturer Address | DALIAN LIAONING, CHINA 116100 CH 116100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-11 |