MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-21 for CURITY NON-ADHERING DRESSINGS 6112 manufactured by Covidien Lp.
[86890526]
Patient Sequence No: 1, Text Type: N, H10
[86890527]
I got this email from our hospital distribution center: for those of you who stock this one in your clean supply rooms: please look at the product today. Some of the packages appear to have some type of condensation on the gauze. Please pull anything that appears to be contaminated and give it to me. I have four of these that were pulled. This is the same problem that happen back seven months ago, that were pulled from surgery. I contacted the executive territory manager and he sent me a shipping label number. I also asked for a follow up letter from the prior incidents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6882173 |
| MDR Report Key | 6882173 |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-08-30 |
| Report Date | 2017-09-14 |
| Date Reported to FDA | 2017-09-14 |
| Date Reported to Mfgr | 2017-09-14 |
| Date Added to Maude | 2017-09-21 |
| 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 | FIBER, MEDICAL, ABSORBENT |
| Product Code | KMF |
| Date Received | 2017-09-21 |
| Model Number | 6112 |
| Catalog Number | 6112 |
| Lot Number | 17A009462 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-21 |