MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-09 for MEDLINE COTTON TIP APPLICATORS MDS202010Z manufactured by Medline Industries, Inc..
[32986165]
Patient Sequence No: 1, Text Type: N, H10
[32986166]
Only 9 instead of 10 countable applicators were in the package when opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5276615 |
| MDR Report Key | 5276615 |
| Date Received | 2015-12-09 |
| Date of Report | 2015-12-08 |
| Date of Event | 2015-12-08 |
| Report Date | 2015-12-08 |
| Date Reported to FDA | 2015-12-08 |
| Date Reported to Mfgr | 2015-12-08 |
| Date Added to Maude | 2015-12-09 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE COTTON TIP APPLICATORS |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Product Code | KXG |
| Date Received | 2015-12-09 |
| Catalog Number | MDS202010Z |
| Lot Number | 01015020001 |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-09 |