MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-11-02 for MDS202000Z manufactured by Medline Industries Inc.
[58934250]
During a procedure under local anesthetic the tip of a cotton tip applicator broke in the procedure site. The surgeon attempted several times to visualize and remove the tip without having to expand the wound site, but was unsuccessful. Patient was placed under general anesthetic for an open wound exploration. Cotton tip was removed without further issues. 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. Due to the increased level of anesthesia this medwatch is being filed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[58934251]
The applicator broke in a wound during a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00112 |
| MDR Report Key | 6072317 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-02 |
| Date of Report | 2016-11-02 |
| Date Mfgr Received | 2016-10-14 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2016-11-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEGAN DEBUS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476433962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | COTTON TIP APPLICATOR |
| Product Code | KXF |
| Date Received | 2016-11-02 |
| Catalog Number | MDS202000Z |
| Lot Number | 01016050004 |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2016-11-02 |