MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for DERMACEA 441002 manufactured by Coviden.
[109450395]
Patient Sequence No: 1, Text Type: N, H10
[109450396]
A covidien raytec surgical sponge frayed during use and a piece was almost left in the patient's axilla. Because of the small incision used, the fiber was not immediately seen in the wound. The md pulled at something she thought was tissue, but was actually the fiber. The md is requesting these sponges not be used in her procedures to mitigate the risk of a foreign body being left in a wound. The "old" non-fraying raytec sponges are available in the quik packs (custom) stocked for the operating room, and the single pack of these used by the md did not fray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7550501 |
| MDR Report Key | 7550501 |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-11 |
| Date of Event | 2018-05-10 |
| Report Date | 2018-05-11 |
| Date Reported to FDA | 2018-05-11 |
| Date Reported to Mfgr | 2018-05-11 |
| Date Added to Maude | 2018-05-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMACEA |
| Generic Name | GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2018-05-29 |
| Catalog Number | 441002 |
| Lot Number | 184274406 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDEN |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-29 |