MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for ARTHREX AR3200-0020 LENS 1085573 manufactured by Arthrex.
[107273571]
Patient had elective lap. Chole. After surgery, noted small break in skin rt. Lower quadrant of abdomen 2cm x 2cm as well as erythematous. Staff unable to determine if related to friction of movement of trocar or related to temperature of camera light that was touching skin. Antibiotic ointment applied and dry sterile dressing. Wound did not heal accordingly. According to patient, wound did not heal. She then saw a wound care physician and had an excision of chronic nonhealing abdominal wound. Diagnosed with full-thickness burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077001 |
| MDR Report Key | 7484197 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-01-26 |
| Date Added to Maude | 2018-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | ARTHREX |
| Generic Name | LAP. CAMERA, ENDOSCOPIC |
| Product Code | FWL |
| Date Received | 2018-05-03 |
| Returned To Mfg | 2018-02-01 |
| Model Number | AR3200-0020 |
| Catalog Number | LENS 1085573 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-03 |