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 2016-04-14 for MDS202055H manufactured by Medline Industries, Inc..
[42674784]
The applicator broke in half when it was inserted into a foot wound and pressure applied. The retained half was surgically removed. No serious injury resulted. 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 possible that this may have been a contributing factor to the reported incident.
Patient Sequence No: 1, Text Type: N, H10
[42674805]
The applicator broke in half when inserted into a foot wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2016-00039 |
| MDR Report Key | 5577462 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-04-14 |
| Date of Report | 2016-04-14 |
| Date of Event | 2016-03-15 |
| Date Mfgr Received | 2016-03-16 |
| Date Added to Maude | 2016-04-14 |
| 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 | DIANE CHRISTENSEN |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | COTTON TIP APPLICATOR |
| Product Code | KXF |
| Date Received | 2016-04-14 |
| Catalog Number | MDS202055H |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2016-04-14 |