MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-09-09 for 90043086 30009 HEAD REST 9" BAGEL 31143137 manufactured by Anatomic Concepts.
[2244810]
It was reported to covidien on (b)(6) 2011 that a customer had an issue with a head rest. The customer reports the head rest caught on fire during surgery, while using 100% oxygen and an es pencil (not manufactured by covidien) resulting in three first degree burns at the hairline. The customer reports that the burns are healing and that the pt should have not scaring. The fire was immediately doused with saline and the pt was treated with a cold compress. The customer also reports that this delayed the procedure due to re-prepping and re-draping of the sterile field.
Patient Sequence No: 1, Text Type: D, B5
[9289743]
Submit date: (b)(4) 2011. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2011-00016 |
| MDR Report Key | 2245226 |
| Report Source | 05,06,07 |
| Date Received | 2011-09-09 |
| Date of Report | 2011-08-23 |
| Date of Event | 2011-08-03 |
| Date Facility Aware | 2011-08-03 |
| Report Date | 2011-08-23 |
| Date Reported to Mfgr | 2011-08-23 |
| Date Mfgr Received | 2011-08-23 |
| Date Added to Maude | 2011-09-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JANICE NEVIUS |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616283 |
| Manufacturer G1 | ANATOMIC CONCEPTS |
| Manufacturer Street | 1691 NORTH DELILAH ST. |
| Manufacturer City | CORONA CA 92879 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92879 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 90043086 30009 HEAD REST 9" BAGEL |
| Generic Name | HEAD REST |
| Product Code | HBM |
| Date Received | 2011-09-09 |
| Model Number | 31143137 |
| Catalog Number | 31143137 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANATOMIC CONCEPTS |
| Manufacturer Address | 1691 NORTH DELILAH ST. CORONA CA 92879 US 92879 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-09 |