MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-03 for VAC 6 INCH NON STERILE E250510FRNSB manufactured by Covidien Lp.
[30610716]
Covidien reference#: (b)(4). The return of the incident sample has been requested. To date, it has not been received for evaluation. Additional questions in regard to the incident have been asked. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[30610717]
The distributor reported that they received a complaint from one of their customers stating that during an adenoidectomy surgery the surgeon noticed a very small burn to the corner of the patient's mouth and as a result a medwatch was filed under reference number (b)(4). The burn was treated with bactroban and the incident suction coagulator was found to be damaged on the suction tube. The date of occurrence was (b)(6) 2015. Patient information could not be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2015-00783 |
| MDR Report Key | 5198732 |
| Date Received | 2015-11-03 |
| Date of Report | 2015-10-07 |
| Date Mfgr Received | 2015-10-07 |
| Date Added to Maude | 2015-11-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VAC 6 INCH NON STERILE |
| Generic Name | ES ACCESSORY, NON STERILE |
| Product Code | BWA |
| Date Received | 2015-11-03 |
| Model Number | E250510FRNSB |
| Catalog Number | E250510FRNSB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-03 |