MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-02-10 for 3M UNIVERSAL ELECTROSURGICAL PAD 9160 manufactured by 3m Health Care.
[22049271]
Based on the info reported, 3m was not provided enough info to draw a conclusion as to factors that contributed to the events. A 3m complaint handler contacted the fda to obtain the complaint facilities' contact info. The facility asked to remain anonymous, therefore, 3m was not able to complete a further investigation into the cause of the adverse event.
Patient Sequence No: 1, Text Type: N, H10
[22126184]
Customer reported to fda ((b) (4)) that a pt received a deep 3rd degree burn at the site of the electrode pad on the thigh during an electrosurgical procedure to the pt shoulder. The customer also reported that injuries were treated by a plastic surgeon and the pt is doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2010-00014 |
| MDR Report Key | 1604010 |
| Report Source | 05 |
| Date Received | 2010-02-10 |
| Date of Report | 2010-01-26 |
| Date of Event | 2009-05-25 |
| Date Mfgr Received | 2010-01-26 |
| Date Added to Maude | 2010-02-18 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MELISSA FRANK |
| Manufacturer Street | BLDG. 275-5W-06 |
| Manufacturer Phone | 6517336791 |
| Manufacturer G1 | 3M VALLEY |
| Manufacturer Street | 600 EAST MEIGS ST. |
| Manufacturer City | VALLEY NE |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M UNIVERSAL ELECTROSURGICAL PAD |
| Generic Name | ELECTROSURGICAL PAD |
| Product Code | ODR |
| Date Received | 2010-02-10 |
| Model Number | 9160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN 55144100 US 55144 1000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-02-10 |