MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for BURN SHEET 30-10 manufactured by Jiangsu Province Jianerkang Medical Dressing Co..
[108909787]
On march 23, 2017, the following was reported burn sheet was applied to infant with burns from accidental coffee spill. Adherence of burn sheet to wound required clinical intervention in operating room to remove burn sheet pieces from wound. The customer was unable to provide sample for evaluation, burn sheet application protocol or patient medical report. The supplier was changed in 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000137528-2017-00001 |
| MDR Report Key | 7533778 |
| Date Received | 2018-05-22 |
| Date of Report | 2017-04-17 |
| Date of Event | 2017-03-07 |
| Date Facility Aware | 2017-03-23 |
| Report Date | 2017-04-19 |
| Date Reported to FDA | 2017-04-19 |
| Date Added to Maude | 2018-05-22 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURN SHEET |
| Generic Name | BURN SHEET |
| Product Code | FPY |
| Date Received | 2018-05-22 |
| Model Number | 30-10 |
| Catalog Number | 30-10 |
| Lot Number | JT36212 |
| Operator | EMERGENCY MEDICAL TECHNICIAN |
| Device Availability | N |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO. |
| Manufacturer Address | ZHIXI TOWN JINTAN CITY, JIANGSU 213251 CH 213251 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-22 |