MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-06-13 for IODOSORB GEL 10G USA CTN 4 66060630 manufactured by Smith & Nephew Medical Ltd..
[77393227]
Patient Sequence No: 1, Text Type: N, H10
[77393228]
It was reported that a patient had a reaction to iodosorb within 10mins of application to wound.
Patient Sequence No: 1, Text Type: D, B5
[78384889]
Patient Sequence No: 1, Text Type: N, H10
[108552791]
The associated complaint devices were not returned for evaluation. Please see attached for investigation results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2017-00163 |
| MDR Report Key | 6636078 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-06-13 |
| Date of Report | 2017-10-20 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2017-05-15 |
| Date Added to Maude | 2017-06-13 |
| 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 | MR MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| 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 | 3 |
| Brand Name | IODOSORB GEL 10G USA CTN 4 |
| Generic Name | BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTION |
| Product Code | KOZ |
| Date Received | 2017-06-13 |
| Model Number | 66060630 |
| Catalog Number | 66060630 |
| Operator | LAY USER/PATIENT |
| 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 HU32BN UK HU32BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-13 |