MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2016-10-25 for INTRASITE GEL manufactured by Smith & Nephew Medical Ltd..
[58294717]
Patient Sequence No: 1, Text Type: N, H10
[58294718]
It was reported that a patient using intrasite gel suffered from an eczematous eruption on the site of application.
Patient Sequence No: 1, Text Type: D, B5
[106171917]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2016-00152 |
| MDR Report Key | 6053616 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2016-10-25 |
| Date of Report | 2017-08-01 |
| Date of Event | 2016-10-06 |
| Date Mfgr Received | 2016-10-06 |
| Date Added to Maude | 2016-10-25 |
| 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 | SMITH & NEPHEW MEDICAL SUZHOU LIMITED |
| Manufacturer Street | NO.12 WUXIANG ROAD. COMPREHENSIVE FREE ZONE,WEST Z |
| Manufacturer City | SUZHOU 215021 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRASITE GEL |
| Generic Name | BANDAGE, LIQUID |
| Product Code | KMF |
| Date Received | 2016-10-25 |
| 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 HU32BN UK HU32BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-25 |