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.
[179739122]
When a bucket drape was placed up on the field to be used to drape the patient, it was noted that the drape had a large cut through it. The packaging was then searched for and found to have had the same cut in it. It was determined that everything on the field had then been contaminated. Everything was removed from the patient and torn down. No incision had been made. The patient was re-prepped and the set up was redone using all new supplies and instrumentation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9720137 |
| MDR Report Key | 9720137 |
| 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 |