MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-13 for WINGS 958B10 manufactured by Covidien.
[80007479]
An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[80007480]
The customer had problems with product. Product would cause pressure ulcers to patients and when it tore, it would leave particles every where, contaminating sterile areas and getting into wounds.
Patient Sequence No: 1, Text Type: D, B5
[110521346]
Submit date: 1/19/2018. An investigation of the reported condition was performed. Because the customer did not supply a recognizable manufacturing lot number, it was not possible to review the device history record (dhr) for this complaint. Because a physical sample/photo was not provided an investigation could not have been completed, therefore the failure mode could not be verified either. Our raw materials are tested for biocompatibility prior to use and there have been no design changes to this product within the past year that would contribute to any increased probability for skin irritation on patients. Based on the complaint trending information, our corrective actions are to notify plant management in order to increase awareness of the issue. Complaint trending will continue to be monitored and corrective actions will be implemented if an increase of this failure mode occurs. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033903-2017-05001 |
| MDR Report Key | 6712092 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-07-13 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2017-06-15 |
| Date Added to Maude | 2017-07-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 525 N.EMERALD ROAD |
| Manufacturer City | GREENWOOD SC 29646 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29646 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINGS |
| Generic Name | BEDDING, DISPOSABLE, MEDICAL |
| Product Code | KME |
| Date Received | 2017-07-13 |
| Model Number | 958B10 |
| Catalog Number | 958B10 |
| Lot Number | 664M71332 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 525 N.EMERALD ROAD GREENWOOD SC 29646 US 29646 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-13 |