MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-08 for MEDLINE STERILE COTTON TIPPED APPLICATORS MDS202000 manufactured by Medline Industries.
[16223389]
Cotton tipped swab used to probe tunnel wound. Tip of applicator broke in the wound requiring sharp debridement for retrieval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036059 |
| MDR Report Key | 3807206 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-05-07 |
| Date of Event | 2014-05-07 |
| Date Added to Maude | 2014-05-14 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE STERILE COTTON TIPPED APPLICATORS |
| Generic Name | MEDLINE STERILE COTTON TIPPED APPLICATORS |
| Product Code | KXG |
| Date Received | 2014-05-08 |
| Model Number | MDS202000 |
| Lot Number | 506524393 |
| ID Number | BAR CODE (01) 20080196716606 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-08 |