MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-18 for 88-5225 manufactured by Carefusion.
[89647975]
Patient Sequence No: 1, Text Type: N, H10
[89647976]
Patient sustained a 1 x 1 3/4 cm burn in left axilla.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6958392 |
| MDR Report Key | 6958392 |
| Date Received | 2017-10-18 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-08-17 |
| Report Date | 2017-08-25 |
| Date Reported to FDA | 2017-08-25 |
| Date Reported to Mfgr | 2017-08-25 |
| Date Added to Maude | 2017-10-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Generic Name | CURVED LEFT DISSECTOR |
| Product Code | KOG |
| Date Received | 2017-10-18 |
| Catalog Number | 88-5225 |
| ID Number | ENDO EMORY PLASTIC RETRACTOR |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Generic Name | CURVED LEFT DISSECTOR |
| Product Code | GDI |
| Date Received | 2017-10-18 |
| Catalog Number | 88-5225 |
| ID Number | ENDO EMORY PLASTIC RETRACTOR |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-18 |