MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-22 for PREMIERPROCOTTON TIPPED APPLICATOR (01)00854344002844 6012 manufactured by Medipack Medical Packaging Mfg. Co..
[36599246]
Patient Sequence No: 1, Text Type: N, H10
[36599247]
Mom of baby was about to use a cotton tipped applicator to clean her baby's ear, after his bath, and she noticed that the wooded stick was poking through the end of the cotton tip swab. She did not use it and brought it to the nurse's attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5384913 |
| MDR Report Key | 5384913 |
| Date Received | 2016-01-22 |
| Date of Report | 2016-01-14 |
| Date of Event | 2016-01-04 |
| Report Date | 2016-01-14 |
| Date Reported to FDA | 2016-01-14 |
| Date Reported to Mfgr | 2016-01-14 |
| Date Added to Maude | 2016-01-22 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | PREMIERPROCOTTON TIPPED APPLICATOR |
| Generic Name | COTTON TIPPED APPLICATOR |
| Product Code | KXG |
| Date Received | 2016-01-22 |
| Model Number | (01)00854344002844 |
| Catalog Number | 6012 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIPACK MEDICAL PACKAGING MFG. CO. |
| Manufacturer Address | 9830 NORWALK BLVD STE. 100 SANTA FE SPGS CA 90670 US 90670 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-22 |