MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-08-21 for 30348 30009 HEAD REST 9" BAGEL 31143137 manufactured by Tyco Healthcare/kendall.
[21989853]
An investigation is currently underway. Upon completion, results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[22180955]
It was reported to tyco healthcare/kendall on 08/15/2007, that the head rest caught on fire when the patient was having debridement. There was some pvp-i prep on the pillow. Patient received 2nd degree burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2007-00029 |
| MDR Report Key | 899968 |
| Report Source | 05,06 |
| Date Received | 2007-08-21 |
| Date of Report | 2007-08-15 |
| Date of Event | 2007-07-30 |
| Report Date | 2007-08-15 |
| Date Reported to Mfgr | 2007-08-15 |
| Date Mfgr Received | 2007-08-15 |
| Date Added to Maude | 2007-08-27 |
| 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 | 3 |
| Manufacturer Contact | JENNIFER REED |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616620 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 30348 30009 HEAD REST 9" BAGEL |
| Generic Name | FOAM POSITIONING PRODUCT |
| Product Code | HBM |
| Date Received | 2007-08-21 |
| Model Number | 31143137 |
| Catalog Number | 31143137 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 877334 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-21 |