MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for INTEGRA MILTEX O-RINGS 28-155 manufactured by Integra.
[177883233]
Product has no instructions for use available per manufacturer. Product labeled non-sterile but manufacturer. Product labeled non-sterile but manufacturer sent certification letter saying product is sterilized, this labeled should be removed. Product is packaged with 100 items yet should only be used for one patient as currently packaged. Fda safety report id # (b)(4). Fda received date 01/30/2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092730 |
| MDR Report Key | 9666266 |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-30 |
| Date Added to Maude | 2020-02-04 |
| 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 | 3 |
| Brand Name | INTEGRA MILTEX O-RINGS |
| Generic Name | LIGATOR, HEMORRHOIDAL |
| Product Code | FHN |
| Date Received | 2020-02-03 |
| Model Number | 28-155 |
| Lot Number | 208372 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |