MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-11-04 for LIGHT GUIDE, A 225F3.5-NA SNOWD 589760 manufactured by Integra Burlington, Ma, Inc.
[16009909]
The dealer reports that this complaint was opened to capture the reported incident with the second patient that was burned. Note: medwatch for patient #1 was filed under 1222895-2013-00026. The patient suffered a small 1st degree burn during a breast reconstruction requiring bacitracin ointment. The case was not delayed and was completed within this surgeons time guidelines. In both instances, the equipment was found to be intact and functional at the time of surgery. No other devices or instrumentation were required as a result of this. These retractors and light cord have not been repaired or required any third party refurbishing. Both incidents involved the same surgeon. The same cable was used in both instances. On (b)(4) 2013, dealer reports one of the following three retractors was used, doesn't know which - tebbetts breast retractors. Product #88-1088, serial #(b)(4); product #88-1087, serial #(b)(4); product #88-1086, serial #(b)(4). On (b)(4) 2013 dealer trying to get light source information from user. Patient #2 of 2.
Patient Sequence No: 1, Text Type: D, B5
[16577591]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2013-00027 |
| MDR Report Key | 3466373 |
| Report Source | 08 |
| Date Received | 2013-11-04 |
| Date of Report | 2013-11-04 |
| Date Mfgr Received | 2013-10-16 |
| Date Added to Maude | 2013-11-14 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT GUIDE, A 225F3.5-NA SNOWD |
| Generic Name | NA |
| Product Code | EQH |
| Date Received | 2013-11-04 |
| Catalog Number | 589760 |
| Lot Number | F215W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON, MA, INC |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-04 |