MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2012-02-14 for TMAX & DISPOSABLE FACE MASK FOR POSITIONING 74-00-04 R1 manufactured by Tenet Medical Engineering.
[2577335]
A pressure ulcer developed on a pt's chin area under the "disposable face mask for positioning" during a beach chair shoulder surgery, prolonged (7hrs) pressure was delivered to the pts chin from a face mask intended to stabilize the pt's head during surgery. In discussions with the health care provider they indicated that the hosp may not have applied the leg belt in the appropriate position, and that during the unusually long procedure the pt may have shifted slightly causing additional pressure to the area. Initial discussions with the health care provider indicated that the pt would recover from the injury without medical or surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
[9724027]
Initial reports from the health care provider indicated that the injury to the pt was minor as healing was expected to occur without medical or surgical intervention. The health care provider and the mfr agree that the cause of the injury was due to the exceptionally long duration of the procedure in conjunction with the mask potentially being too tight at the beginning of the surgery or becoming too tight as a result of pt movement during the procedure. It was discovered that the pt leg restraint was not being used appropriately and may have contributed to pt movement if movement occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681741-2011-00001 |
| MDR Report Key | 2508474 |
| Report Source | 00,06 |
| Date Received | 2012-02-14 |
| Date of Report | 2011-02-11 |
| Date of Event | 2011-01-07 |
| Date Mfgr Received | 2011-01-14 |
| Date Added to Maude | 2012-07-30 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BRENT KING |
| Manufacturer Street | #203 - 11979 40TH ST. S.E. |
| Manufacturer City | CALGARY, AB |
| Manufacturer Country | CA |
| Manufacturer Phone | 5710750 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMAX & DISPOSABLE FACE MASK FOR POSITIONING |
| Generic Name | BEACH CHAIR AND FACE MASK |
| Product Code | BWN |
| Date Received | 2012-02-14 |
| Model Number | 74-00-04 R1 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TENET MEDICAL ENGINEERING |
| Manufacturer Address | #203 - 11979 40TH ST. S.E. CALGARY, AB T2Z4M3 CA T2Z4M3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-14 |