MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2009-12-11 for CAUTERY 8442000 ACCU-TEMP 10PK FINE TIP manufactured by Medtronic Xomed, Inc..
[1455180]
Dr was performing a blepharoplasty on the right and left eyelids. The pt was placed under im section with sterile prep (betadine) and drape. While performing the surgery on the left he was cauterizing the medial fat pad "at least one inch away" in the crease of the eyelid when the medial 2/3 of upper and lower eyelashes singed/burned. Wet gauze was placed on the field earlier, but not over lashes at time of burn. The pt's eyes were closed and the pt's vision was not involved/damaged.
Patient Sequence No: 1, Text Type: D, B5
[8341563]
A medwatch form was not received from the reporter. Any missing or incomplete data on form 3500a is the result of info not being provided or released by the reporter despite attempts to obtain the required info. This product was being used for treatment. The pt's weight was not obtained by the facility, stated the pt was small framed. Additional follow up medical treatment performed included: latisse, hyperbaric oxygen treatment sessions, eyelash extensions, and a sclera injection at the site of a scab (inner rim margin of upper eyelid). The pt is currently recovering with redness and discomfort while blinking. The topical solution latisse advertised safety info stated "the most common side effects after using latisse solution are an itching sensation in the eyes and / or eye redness. " a review of the complaint history indicates that this is the first report for this product lot and only two other events of a similar nature (i. E. Singed eyelash/eyebrow) has been reported for this product line looking back at complaint records for the last 5 years. No anomalies were found in the electronic mfg document. Examination of the tip under a microscopic showed the product functioned as intended with no visible anomalies. Electrical tests per specifications showed resistance measured 0. 5 ohms and voltage measured 1. 9 volts for 2 seconds which is in conformance with the product specifications. Instruction for use includes but is not limited to; "fire warning: heat generated by the tip can ignite flammable materials. Do not use in the presence of flammable materials such as facial hair, preparation agents, alcohol vapors, drapes, or gowns. Proper surgical technique, such as the application of water-based lubricant to facial hair near the surgical site of electrocautery use, must be followed to prevent potential pt injury. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2009-00053 |
| MDR Report Key | 1559772 |
| Report Source | 05,08 |
| Date Received | 2009-12-11 |
| Date of Report | 2009-11-13 |
| Date of Event | 2009-11-11 |
| Date Facility Aware | 2009-11-11 |
| Date Mfgr Received | 2009-11-13 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2009-12-17 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAUTERY 8442000 ACCU-TEMP 10PK FINE TIP |
| Generic Name | 86 HQP |
| Product Code | HQP |
| Date Received | 2009-12-11 |
| Returned To Mfg | 2009-11-20 |
| Model Number | 8442000 |
| Catalog Number | 8442000 |
| Lot Number | 60504100 |
| ID Number | SBAJVBLCPA |
| Device Expiration Date | 2013-03-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-12-11 |