MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-05-13 for GEL-E DONUT - SMALL 92025-B manufactured by Philips Respironics - Chmv.
[15106834]
Children's medical ventures (chmv) received a report of a product issue associated with the small gel-e donut positioning devices. The complaint allegation reports an issue of mold associated with five cases of the product. 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. No unique product identifiers such as lot numbers or expiration dates have been reported.
Patient Sequence No: 1, Text Type: D, B5
[15288752]
(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 | 3007056120-2014-00015 |
| MDR Report Key | 3912184 |
| Report Source | 99 |
| Date Received | 2014-05-13 |
| Date of Report | 2014-04-14 |
| Date Mfgr Received | 2014-04-14 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RUSTY KELLY |
| Manufacturer Street | 12151 RESEARCH PKWY SUITE 200 |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal | 32826 |
| Manufacturer Phone | 4074556166 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEL-E DONUT - SMALL |
| Product Code | FMP |
| Date Received | 2014-05-13 |
| Model Number | 92025-B |
| Lot Number | NOT GIVEN |
| 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 |