MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for SURGICAL CLIPPER 316449 manufactured by Carefusion 2200, Inc..
[146211887]
The patient developed a skin tear on his right lower abdomen when rn was clipping the patient's abdomen using the regular blade. The surgical site, including the skin tear was prepped with chloraprep. The physician was notified prior to start of the operating room case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8645229 |
| MDR Report Key | 8645229 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-04-09 |
| Report Date | 2019-05-13 |
| Date Reported to FDA | 2019-05-13 |
| Date Reported to Mfgr | 2019-05-28 |
| Date Added to Maude | 2019-05-28 |
| 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 | RISK MANAGER |
| 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 | SURGICAL CLIPPER |
| Generic Name | SURGICAL CLIPPER |
| Product Code | LWK |
| Date Received | 2019-05-28 |
| Model Number | 316449 |
| Catalog Number | 316449 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC. |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-28 |