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 2016-06-08 for IODOSORB POWDER manufactured by Smith & Nephew Medical Ltd..
[46770786]
Patient Sequence No: 1, Text Type: N, H10
[46770787]
It was reported that the patient has found to be allergic to iodosorb powder on patch testing.
Patient Sequence No: 1, Text Type: D, B5
[55112726]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2016-00060 |
| MDR Report Key | 5705423 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-08 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-04-29 |
| Date Mfgr Received | 2016-05-13 |
| Date Added to Maude | 2016-06-08 |
| 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 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | PERSTORP SPECIALTY CHEMICALS A INDUSTRIPARKEN |
| Manufacturer City | PERSTORP 28491 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 28491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IODOSORB POWDER |
| Generic Name | BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTION |
| Product Code | KOZ |
| Date Received | 2016-06-08 |
| Returned To Mfg | 2016-06-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2016-06-08 |