MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-08 for DRAPE EXTREMITY PACK LF DYNJ24228C manufactured by Medline.
[2356606]
While draping the c-arm for a removal of a foreign body, it was noted the c-arm drape was defective with a large hole making the drape unusable. The drape was removed from the operative field. The scrub person re-gloved. A new drape was delivered to the field. No harm came to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2341211 |
| MDR Report Key | 2341211 |
| Date Received | 2011-11-08 |
| Date of Report | 2011-11-08 |
| Date of Event | 2011-11-01 |
| Report Date | 2011-11-08 |
| Date Reported to FDA | 2011-11-08 |
| Date Added to Maude | 2011-11-17 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAPE EXTREMITY |
| Generic Name | DRAPE |
| Product Code | MMP |
| Date Received | 2011-11-08 |
| Model Number | PACK LF |
| Catalog Number | DYNJ24228C |
| Lot Number | 11HD2765 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-08 |