MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-31 for GEL-E DONUT 92025-A manufactured by Philips Respironics, Inc..
[2768609]
Children's medical ventures (chmw) rec'd a voluntary medwatch (b)(4) on (b)(4) 2012. The report detailed that the hospital retrieved a gel-e donut from a clean room in an unopened bag. The bag was noted to be damp when opened. A black spot was reportedly on the bag that appeared to be mold. A mold like substance was also reported to be on the back side of the label. The customer reported that they are retaining the donut and bag, there is no allegation of pt harm. The device is a positioning aid and reportedly could not be used as intended. The complaint issue alleged by the customer was not able to be confirmed because the product was not returned to the mfr for eval. Although the alleged event could not be substantiated, no resulting effect on a pt or potential user has been reported. The instructions for use state that before use, remove the outer plastic bag and wipe all surfaces with an antibacterial agent. The urethane bag may feel moist when removed from the plastic bag. Dry before use.
Patient Sequence No: 1, Text Type: D, B5
[10116071]
Based on all available info, the mfr concludes that this issue may have caused or contributed to a failure of the device to perform part or all of its intended functions, or resulted in some level of customer dissatisfaction with the performance of the product, but does not present an increased risk to pt safety and no further action is appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2012-00010 |
| MDR Report Key | 2632706 |
| Report Source | 05 |
| Date Received | 2012-05-31 |
| Date of Report | 2012-05-01 |
| Date of Event | 2012-03-27 |
| Date Mfgr Received | 2012-05-01 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2012-10-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS FERGUSON, SR. MANAGER QUA |
| Manufacturer Street | 191 WYNGATE DRIVE |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 4123808804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEL-E DONUT |
| Generic Name | POSITIONING AID |
| Product Code | FRP |
| Date Received | 2012-05-31 |
| Model Number | 92025-A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS, INC. |
| Manufacturer Address | MONROEVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-31 |