MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-11-17 for ALLEN C-PRONE COMFORT MASK A-70310-A1 A-70310 manufactured by Allen Medical.
[16834403]
On (b)(6), 2009, an allen sales rep was contacted by a user facility with the report that a female pt had experienced a post-operative rash & bruising following a lengthy positioning case. It was later learned that the pt had developed a pressure ulcer on her chin following a 10-hour-long spinal surgery. Additional treatment is required to resolved this condition.
Patient Sequence No: 1, Text Type: D, B5
[17052855]
Allen medical sent a qa mgr and the allen sales representative to the customer site for an investigation. On (b)(6) 2009, they observed a similar case at this facility during which the same device and products were used as on (b)(6) 2009. After watching the case, it is believed that the initial event likely resulted from improper positioning of the pt on the face mask, as the pt's chin was likely resting on the plastic chin bar of the c-prone head positioner instead of on the foam face mask. No device defects were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221538-2009-00012 |
| MDR Report Key | 1541454 |
| Report Source | 06 |
| Date Received | 2009-11-17 |
| Date of Report | 2009-10-19 |
| Date of Event | 2009-10-15 |
| Date Mfgr Received | 2009-10-19 |
| Date Added to Maude | 2011-03-21 |
| 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 | NANCY ROYALTY, DIRECTOR |
| Manufacturer Street | ONE POST OFFICE SQUARE |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal | 01720 |
| Manufacturer Phone | 8885214277 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEN C-PRONE COMFORT MASK |
| Generic Name | COMFORT MASK |
| Product Code | NMC |
| Date Received | 2009-11-17 |
| Model Number | A-70310-A1 |
| Catalog Number | A-70310 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL |
| Manufacturer Address | ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-11-17 |