MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for STERI-DRAPE? 1013 manufactured by 3m Company.
[139550436]
Sterile barrier issue with c-arm drapes x 2 w/ same lot number. The first drape seemed to be melted & stuck together; 2nd drape was split open, not intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8443241 |
| MDR Report Key | 8443241 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-03-06 |
| Report Date | 2019-03-08 |
| Date Reported to FDA | 2019-03-08 |
| Date Reported to Mfgr | 2019-03-22 |
| Date Added to Maude | 2019-03-22 |
| 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? |
| Generic Name | DRAPE, STERILE SURGICAL, X-RAY IMAGE INTENSIFIER DRAPE |
| Product Code | PUI |
| Date Received | 2019-03-22 |
| Catalog Number | 1013 |
| Lot Number | 202312XD |
| Device Availability | N |
| Device Age | 1 DA |
| 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 | 2019-03-22 |