MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for STERI-DRAPE? IOBAN? 2 6659 manufactured by 3m Company.
[179739029]
After the same type of drape was found to be contaminated, we closely inspected another bucket drape that was intended to be opened up onto the field. Upon close inspection there it was noted that there was a hair on the inside of the drape which could be felt through the packaging of the item. The drape was immediately removed from the room and was never opened onto the field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9720110 |
| MDR Report Key | 9720110 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-27 |
| Report Date | 2020-01-28 |
| Date Reported to FDA | 2020-01-28 |
| Date Reported to Mfgr | 2020-02-18 |
| Date Added to Maude | 2020-02-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | STERI-DRAPE? IOBAN? 2 |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2020-02-18 |
| Model Number | 6659 |
| Catalog Number | 6659 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | 3M CENTER, 2510 CONWAY AVE. BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |