MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for SOLOSITE WOUND GEL 3OZ GB449600 manufactured by Smith & Nephew Medical Ltd..
[42380582]
Patient Sequence No: 1, Text Type: N, H10
[42380583]
It was reported that patient had a split thickness skin graft, mostly healed before using solosite with gauze covering. Solosite applied on (b)(6). By (b)(6) the wound had developed a blistering rash. Dr. Worked with patient to renew healing of the wound with notable improvement. The patient's home care practitioner again applied solosite to the wound and within 24 hours the wound was blistered and denuded, resembling a 2nd degree burn.
Patient Sequence No: 1, Text Type: D, B5
[46702244]
Please see the attached document containing additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2016-00039 |
| MDR Report Key | 5566697 |
| Date Received | 2016-04-11 |
| Date of Report | 2016-03-31 |
| Date of Event | 2016-03-21 |
| Date Mfgr Received | 2016-03-31 |
| Date Added to Maude | 2016-04-11 |
| 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 G1 | ENCUBE ETHICALS PRIVATE LIMITED |
| Manufacturer Street | UNIT NO. 24, STEELMADE INDL ES |
| Manufacturer City | ANDHERI 400059 |
| Manufacturer Country | IN |
| Manufacturer Postal Code | 400059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLOSITE WOUND GEL 3OZ |
| Generic Name | DRESSING, WOUND AND BURN |
| Product Code | MGQ |
| Date Received | 2016-04-11 |
| Model Number | GB449600 |
| Catalog Number | GB449600 |
| 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 | 2016-04-11 |