MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for DURAPREP SURGICAL SOLUTION manufactured by 3m.
[122852381]
Nurse was preparing to prep patient with product and upon opening sterile package, the contaminate wrapped around the cotton tip was discovered and reported to the operating room director. Package was isolated and turned into the materials management director.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080318 |
| MDR Report Key | 7930298 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-10-01 |
| Date of Event | 2018-09-28 |
| Date Added to Maude | 2018-10-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DURAPREP SURGICAL SOLUTION |
| Generic Name | APPLICATOR ABSORBED TIPPED STERILE |
| Product Code | KXG |
| Date Received | 2018-10-02 |
| Lot Number | 0006448375 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-02 |