MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-13 for ALLEN COMFORT MASK DISPOSABLE A-70310-A4 A-70310 manufactured by Allen Medical.
[15780724]
On (b)(6) 2012, an operating room manager from (b)(6) hospital of (b)(6), contacted an allen representative to report a non-permanent patient incident which required treatment. The subject of the case was a female patient having spine surgery on (b)(6) 2012, which lasted approximately five hours. The patient, who is reportedly allergic to latex, developed a post-operative rash on her face where it contacted the allen comfort mask. The staff reported the patient rash was treated topically and was reportedly subsiding a week later when it was reported to the allen rep.
Patient Sequence No: 1, Text Type: D, B5
[15869128]
It is unclear if the patient was prepped or the surfaces cleaned with a substance which could have caused the reaction - or if there was significant movement during the five-hour case which could have caused this reaction. The single use disposable product is latex-free. This was verified by the material vendor. The subject product and unused product from the same case or lot was not returned to us by the customer for this investigation. The patient was said to be recovering a week after the report, when it was reported. Full recovery could not be confirmed as the reporter has not yet answered our contact attempts. No conclusions can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221538-2012-00005 |
| MDR Report Key | 2661564 |
| Report Source | 05 |
| Date Received | 2012-07-13 |
| Date of Report | 2012-06-13 |
| Date of Event | 2012-06-06 |
| Date Mfgr Received | 2012-06-13 |
| Date Added to Maude | 2012-08-01 |
| 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 COMFORT MASK DISPOSABLE |
| Generic Name | COMFORT MASK |
| Product Code | NMC |
| Date Received | 2012-07-13 |
| Model Number | A-70310-A4 |
| Catalog Number | A-70310 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL |
| Manufacturer Address | ACTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-13 |