MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-13 for GEL-E DONUT - EXTRA SMALL 92025-A manufactured by Philips Respironics - Chmv.
[21496800]
Children's medical ventures (chmv) received (b)(4) from the fda on (b)(4) 2014, informing the business of a medwatch report detailing a product issue associated with the extra-small gel-e donut positioning devices. The complaint allegation states that a customer found a mold like substance on the surface and inside the gel. Two of the affected product were reportedly opened in the patient's room before noticing the issue. An additional three affected products were also reportedly found in storage. There is no allegation of any affected products being put into patient use and no allegation of patient harm has been reported. The complaint issue alleged by the customer was not able to be confirmed because the product has not been received by the manufacturer for evaluation. The customer reported the expiration date of the product as being 07/29/2014.
Patient Sequence No: 1, Text Type: D, B5
[21737594]
(b)(4). The gel products are intended to provide support for infants in a hospital environment and a caregiver is to be present during use. Normal use will conform to accepted medical practice and to the labeling instructions. The gel products instructions for use state that before use, remove the outer plastic bag and wipe all surfaces with an antibacterial agent. The instructions for use further state to cover with a disposable cover or soft cloth before patient use. Chmv has determined that due to an increased amount of customer complaints associated with the reported issue, a formal investigation has been initiated. Once the investigation has been concluded, a follow-up information report will be filed detailing the findings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2014-00014 |
| MDR Report Key | 3912187 |
| Report Source | 05 |
| Date Received | 2014-05-13 |
| Date of Report | 2014-05-05 |
| Date Mfgr Received | 2014-04-16 |
| Device Manufacturer Date | 2013-01-28 |
| Date Added to Maude | 2014-07-15 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RUSTY KELLY |
| Manufacturer Street | 12151 RESEARCH PARKWAY SUITE 200 |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal | 32826 |
| Manufacturer Phone | 4074556166 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEL-E DONUT - EXTRA SMALL |
| Product Code | FMP |
| Date Received | 2014-05-13 |
| Model Number | 92025-A |
| Device Expiration Date | 2014-07-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS - CHMV |
| Manufacturer Address | 191 WYNGATE DR MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-13 |