MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-08 for CURITY NON-ADHERING DRESSINGS 6112 manufactured by Covidien.
[69363135]
Patient Sequence No: 1, Text Type: N, H10
[69363136]
A staff member in surgery noticed spots on the 3x3 non-adherent strips. There were 14 strips pulled from our stock in surgery and the distribution center. The spots were in the same area on all of the strips. I will send a picture to go with this report. Manufacturer response for oil emulsion bandage, (brand not provided) (per site reporter): when i contacted the manufacturer, they said i had to contact the sales rep. I sent the strips to him.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6386832 |
| MDR Report Key | 6386832 |
| Date Received | 2017-03-08 |
| Date of Report | 2017-02-28 |
| Date of Event | 2017-02-17 |
| Report Date | 2017-02-28 |
| Date Reported to FDA | 2017-02-28 |
| Date Reported to Mfgr | 2017-02-28 |
| Date Added to Maude | 2017-03-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | CURITY NON-ADHERING DRESSINGS |
| Generic Name | BANDAGE, LIQUID |
| Product Code | KMF |
| Date Received | 2017-03-08 |
| Returned To Mfg | 2017-02-20 |
| Catalog Number | 6112 |
| Lot Number | 16H084062 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN RD. AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-08 |