MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-04 for COTTON TIP WOOD APPLICATOR MDS202000 manufactured by Medline Industries, Inc..
[5570337]
The applicator broke when it was inserted into a deep tunneling wound.
Patient Sequence No: 1, Text Type: D, B5
[12879018]
It was reported that the applicator broke while being inserted into a deep tunneling wound. Attempts were made to gather additional details, but no other information was provided by the facility. No sample was returned for evaluation and a root cause has not been determined. A caution statement on the labeling indicates that this device should not be used in procedures which may require excessive pressure. It is not known if this was a contributing factor to the reported incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2015-00008 |
| MDR Report Key | 4495673 |
| Report Source | 05,06 |
| Date Received | 2015-02-04 |
| Date of Report | 2015-01-30 |
| Date Mfgr Received | 2015-01-02 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-02-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2015-02-04 |
| Catalog Number | MDS202000 |
| Lot Number | 507134688 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-02-04 |