MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-30 for COTTON TIP WOOD APPLICATOR MDS202010Z manufactured by Medline Industries, Inc..
[19402070]
The wooden stick broke after being inserted into a sacral wound.
Patient Sequence No: 1, Text Type: D, B5
[19534927]
The applicator broke in half when inserted into a sacral abscess to measure the undermining of the wound. The wound had thick, purulent drainage. The retained half of the applicator was retrieved in a physician office without further incident. No sample was returned for evaluation and a root cause had not been determined. A caution statement on the labeling indicates that this device should not be used in procedures which may require excessive pressure. We cannot rule out the possibility that pressure exerted on the stick could have been a cause or contributing factor to the reported incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00127 |
| MDR Report Key | 4381399 |
| Report Source | 05 |
| Date Received | 2014-12-30 |
| Date of Report | 2014-12-26 |
| Date of Event | 2014-12-03 |
| Date Mfgr Received | 2014-12-03 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-01-06 |
| 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 | 3 |
| 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 | 2014-12-30 |
| Catalog Number | MDS202010Z |
| Lot Number | 507239725 |
| 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. Required No Informationntervention | 2014-12-30 |