MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-03 for DERMACEA N/A 441601 manufactured by Covidien/medtronic.
[101713250]
On 14-feb-2017 resoyrce optimization and innovation was notified through customer service of a complaint logged by (b)(6) regarding gauze leaving strings on the surgical site. After contacting customer service to further investigate the customer stated that the surgeon noticed strings on the surgical site when the surgeon utilized the gauze to wipe the surgical site. We quickly "was" the area off but stated if the strings were left inside the surgical site it would start an infection. The reported gauze is a component utilized by roi in the manufacture of custom surgical pack (b)(4) lap pack lot 3038779b.
Patient Sequence No: 1, Text Type: N, H10
[101713251]
X-ray gauze left strings on the surgical site when the surgeon utilized the gauze to wipe the surgical site. Kit lawson (b)(4) lap pack lot #038779b.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004513970-2017-00001 |
| MDR Report Key | 7312125 |
| Date Received | 2018-03-03 |
| Date of Report | 2017-02-14 |
| Date Mfgr Received | 2017-02-14 |
| Device Manufacturer Date | 2016-10-12 |
| Date Added to Maude | 2018-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer G1 | RESOURCE OPTIMIZATION AND INNOVATION. LLC |
| Manufacturer Street | 2909 N. NEERGARD AVE |
| Manufacturer City | SPRINGFIELD MO 65803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 65803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DERMACEA |
| Generic Name | X-RAY SPONGES |
| Product Code | NAB |
| Date Received | 2018-03-03 |
| Model Number | N/A |
| Catalog Number | 441601 |
| Lot Number | 17051204 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN/MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-03 |