MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-09-16 for REPLICARE ULTRA 10X10 66801617 manufactured by Smith & Nephew Medical Ltd..
[54922956]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[54922957]
It was reported that 6 days after putting replicare ultra on the skin of a right elbow, the skin under the dressing had an eruption of blisters.
Patient Sequence No: 1, Text Type: D, B5
[68396568]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2016-00127 |
| MDR Report Key | 5955779 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-16 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2016-09-08 |
| Date Added to Maude | 2016-09-16 |
| 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 | MRS CLAUDIA ODOY |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer Phone | 0628320660 |
| Manufacturer G1 | EUROMED, INC |
| Manufacturer Street | 49 PLAIN STREET |
| Manufacturer City | NORTH ATTLEBORO MA 02760 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02760 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPLICARE ULTRA 10X10 |
| Generic Name | DRESSING, WOUND AND BURN, OCCLUSIVE |
| Product Code | MGP |
| Date Received | 2016-09-16 |
| Model Number | 66801617 |
| Catalog Number | 66801617 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-16 |