MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-02-12 for CONFORMANT 2 WOUND VEIL 4"X4" SHEET 5955044 manufactured by Winner Industries (shenzhen) Co. Ltd.
[1013794]
In the course of her treatment, part of the dressing used was a smith-nephew conformant would veil. The customer said the home health care workers never removed or replaced the wound veil when the dressing was changed (3 times/week). The wound is now scabbed over and the scab has fallen off but the wound veil material is imbedded in the area and edges of the material are evident. The patient is concerned about the possibility of infection from the veil substance and afraid of any other unknowns that might arise from having this material left in her person. She has an appointment with her doctor today.
Patient Sequence No: 1, Text Type: D, B5
[8167979]
Samples not expected, additional patient information provided has been sent to manufacturer for assessment of event. Final conclusions and full analysis to be submitted in a supplement report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017593-2009-00002 |
| MDR Report Key | 1314068 |
| Report Source | 04 |
| Date Received | 2009-02-12 |
| Date of Report | 2009-02-11 |
| Date of Event | 2009-01-14 |
| Date Facility Aware | 2009-01-14 |
| Report Date | 2009-02-11 |
| Date Reported to FDA | 2009-02-12 |
| Date Reported to Mfgr | 2009-01-14 |
| Date Mfgr Received | 2009-01-14 |
| Date Added to Maude | 2009-02-23 |
| 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 Street | 970 LAKE CARILLON DR., STE 110 |
| Manufacturer City | ST. PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal | 33716 |
| Manufacturer Phone | 7273921261 |
| Manufacturer G1 | WINNER INDUSTRIES (SHENZHEN) CO. LTD |
| Manufacturer Street | WINNER INDUSTRIAL PARK BULONG RD |
| Manufacturer City | LONGHUA TOWN, SHENZHEN |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFORMANT 2 WOUND VEIL 4"X4" SHEET |
| Generic Name | DRESSING, WOUND & BURN, OCCLUSIVE (MGP) |
| Product Code | MGP |
| Date Received | 2009-02-12 |
| Model Number | 5955044 |
| Lot Number | 080102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WINNER INDUSTRIES (SHENZHEN) CO. LTD |
| Manufacturer Address | WINNER INDUSTRIAL PARK BULONG RD LONGHUA TOWN, SHENZHEN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-12 |