MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-26 for THERASKIN 1X2 101TSS manufactured by Soluble Systems.
[53909041]
Patient being seen in wound clinic for a left calf wound. Staff went to prepare the theraskin in normal saline and saw what appeared to be black mold on the product. Item not used on patient. Another theraskin was prepared and utilized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064440 |
| MDR Report Key | 5917247 |
| Date Received | 2016-08-26 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-08-25 |
| Date Added to Maude | 2016-08-31 |
| 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 |
| 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 | THERASKIN 1X2 |
| Generic Name | THERASKIN 1X2 |
| Product Code | NAE |
| Date Received | 2016-08-26 |
| Returned To Mfg | 2016-08-26 |
| Model Number | 101TSS |
| Device Expiration Date | 2019-06-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLUBLE SYSTEMS |
| Manufacturer Address | NEWPORT NEWS VA 23606 US 23606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-26 |