MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-07-25 for ACCU-TEMP CAUTERY 8442000 manufactured by Beaver Visitec International, Inc..
[2836762]
(b)(4). Customer reported verbatim, "during surgery, a swab caught fire and burned the surgeon's thumb and the side of the nose and cheek of the patient. " repeated attempts to reach dr. (b)(6) were made since (b)(6). He returned our call on (b)(6) 2012. Our conversation found that surgery was conducted to remove a tumor on the eye lid. The surgeon decided to do a cauterization of a small artery next to the lacrimal gland and close to the cornea. To provide easier access he used a gauze (100% cotton, non-woven) placing it under his left thumb to help make the area where the cauterization easier to reach. As cauterization started, he felt a sharp pain in his left thumb and started smelling something burning. Almost immediately the patient complained indicating a sharp pain on the side of her nose. Dr. (b)(6) immediately stopped and as he removed his thumb away from the patient, he noticed that the gauze under his thumb had disintegrated leaving a red mark on his thumb and on the patient's nose. The next day the red mark on dr. (b)(6)'s thumb was gone. However, the patient was still showing a red mark and cream used to treat surface burns was applied. The patient today does not show any mark. Dr. (b)(6) has not issues with his thumb and has been able to perform surgeries without issues.
Patient Sequence No: 1, Text Type: D, B5
[10057402]
Product has been returned, but it appears to be a bvi manufactured unit. This is not consistent with the lot number reported. This product line was recently acquired by medtronic and is now manufactured at beaver visitec international. However, the reported lot number of this product signifies that it was manufactured by medtronic prior to this acquisition. Investigation is in progress, which includes information from medtronic regarding date of mfr, expiration date, and complaint trending. Expect a follow-up report to be provided on or about (b)(4) 2012.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1211998-2012-00003 |
| MDR Report Key | 2673045 |
| Report Source | 06,07 |
| Date Received | 2012-07-25 |
| Date of Report | 2012-07-23 |
| Date of Event | 2012-07-10 |
| Date Mfgr Received | 2012-07-10 |
| Date Added to Maude | 2012-08-01 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN BOURDON |
| Manufacturer Street | 411 WAVERLEY OAKS ROAD |
| Manufacturer City | WALTHAM MA 024528405 |
| Manufacturer Country | US |
| Manufacturer Postal | 024528405 |
| Manufacturer Phone | 7819067917 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCU-TEMP CAUTERY |
| Generic Name | ACCU-TEMP CAUTERY 1/2 SHAFT W/FINE TIP |
| Product Code | HAM |
| Date Received | 2012-07-25 |
| Returned To Mfg | 2012-07-19 |
| Model Number | NA |
| Catalog Number | 8442000 |
| Lot Number | 71674800 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEAVER VISITEC INTERNATIONAL, INC. |
| Manufacturer Address | WALTHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-25 |