MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-18 for COTTON TIP WOODEN APPLICATOR MDS202000 manufactured by Medline Industries, Inc..
[4780693]
The tip broke off the applicator when inserted into a tunneled heel wound.
Patient Sequence No: 1, Text Type: D, B5
[12233006]
The applicator tip broke off when it was inserted into a tunneled heel wound. A piece measuring approx 2. 5 cam was retrieved from the wound. Attempts were made to gather add'l details but no other info was provided by the facility. No sample was returned for eval 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 possible that this may have been a contributing factor to the reported incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00070 |
| MDR Report Key | 4001472 |
| Report Source | 06 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-07-15 |
| Date of Event | 2014-05-07 |
| Date Mfgr Received | 2014-06-16 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2014-08-13 |
| 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 | RISK MANAGER |
| 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 WOODEN APPLICATOR |
| Product Code | KXG |
| Date Received | 2014-07-18 |
| Catalog Number | MDS202000 |
| Lot Number | 506524393 |
| 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; 2. Required No Informationntervention | 2014-07-18 |