MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for CURITY NON-ADHERENT STRIPS manufactured by Covidien.
[138910783]
Wound dressings were found to be contaminated. These dressings were being used on our patients ongoing until the discovery of possible contamination due to spots found on dressing in sealed package. Sent to lab to find out if spots were growing anything. Found paecilomyces. When we learned of possible contamination, we pulled all products from all patient care areas and notified manufacturer. Rch checked patients back six months and did not find any that tested for paecilomyces. Therefore, no patient harm found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084888 |
| MDR Report Key | 8420615 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-02-11 |
| Date Added to Maude | 2019-03-14 |
| 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 | RISK MANAGER |
| 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 | CURITY NON-ADHERENT STRIPS |
| Generic Name | BANDAGE LIQUID |
| Product Code | KMF |
| Date Received | 2019-03-13 |
| Lot Number | 18H188162 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-13 |