MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-10 for LEEP PATIENT PAD 6050P manufactured by Conmed.
[1381929]
Leep procedure was performed. Patient complained on (b)(6) 2010 that there was a red area in outline of grounding pad. Patient declared pain and was seen on (b)(6) 2010 and a fading to brown outline on upper right thigh was noted. On (b)(6) 2010 at her exam and f/u visit the area is dark brown like suntan and she is being referred to a plastic surgeon for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8722341]
Pad was reported on the initial summary to have been conformed and assured to the in place patient complained seven days after procedure of a "fading to brown outlines on right upper thigh. " her health care provider referred her to a plastic surgeon to follow up.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2010-00004 |
| MDR Report Key | 1812558 |
| Report Source | 05,06 |
| Date Received | 2010-08-10 |
| Date of Report | 2010-08-10 |
| Date of Event | 2010-07-01 |
| Date Mfgr Received | 2010-07-30 |
| Date Added to Maude | 2012-02-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEEP PATIENT PAD |
| Generic Name | RETURN PAD |
| Product Code | ODR |
| Date Received | 2010-08-10 |
| Catalog Number | 6050P |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-08-10 |