MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for INTRASITE GEL APPLIPAK 8G CTN 10 7308 manufactured by Smith & Nephew Medical Ltd..
[136974928]
Patient Sequence No: 1, Text Type: N, H10
[136974929]
It was reported that the patient has a wound over his left eye and has been using the intrasite gel with the dressing. At night the intrasite has been leaking into his eye causing him pain. He has had to wash it regularly. It has left the patient with the effect of dry eyes at nights and he have to get up and bathe his eyes. After three weeks the patient still have to get up in the night to bath both eyes to release eye lids to wash eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2019-00125 |
| MDR Report Key | 8364142 |
| Date Received | 2019-02-22 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-25 |
| Date Added to Maude | 2019-02-22 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU3 2BN |
| Manufacturer Phone | 4407940038 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTRASITE GEL APPLIPAK 8G CTN 10 |
| Generic Name | DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
| Product Code | NAE |
| Date Received | 2019-02-22 |
| Catalog Number | 7308 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-02-22 |