MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-18 for COTTON TIP WOOD APPLICATOR MDS202000 manufactured by Medline Industries, Inc..
[5034547]
The cotton tip came off the applicator when measuring the depth of a wound.
Patient Sequence No: 1, Text Type: D, B5
[12589942]
The cotton tip came off the applicator as the physician was measuring the depth of a wound with the applicator. The depth of the insertion is not known. The cotton was retrieve via surgical d? Bridement without further incident. The issue was confirmed with the returned sample. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00105 |
| MDR Report Key | 4278991 |
| Report Source | 05,06 |
| Date Received | 2014-11-18 |
| Date of Report | 2014-11-14 |
| Date of Event | 2014-10-21 |
| Date Mfgr Received | 2014-10-22 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2014-11-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COTTON TIP WOOD APPLICATOR |
| Product Code | KXG |
| Date Received | 2014-11-18 |
| Catalog Number | MDS202000 |
| Lot Number | 506963984 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-11-18 |