MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-06-16 for PERSTORP OINTMENT 40 6602125040 GB6602125040 manufactured by Smith & Nephew Medical Ltd..
[47512329]
.
Patient Sequence No: 1, Text Type: N, H10
[47512330]
It was reported that a patient suffered discoloration to the skin in the hip area after being treated with iodosorb. It was alleged that iodosob dripped onto, and stained, the skin. It is brown in color and is nto fading despite attempts to resolve the situation by the hcp.
Patient Sequence No: 1, Text Type: D, B5
[60768235]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2016-00068 |
| MDR Report Key | 5728973 |
| Report Source | CONSUMER |
| Date Received | 2016-06-16 |
| Date of Report | 2016-06-15 |
| Date Mfgr Received | 2016-06-15 |
| Date Added to Maude | 2016-06-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL 33716 |
| Manufacturer Country | UK |
| Manufacturer Postal Code | 33716 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSTORP OINTMENT 40 |
| Generic Name | BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTION |
| Product Code | KOZ |
| Date Received | 2016-06-16 |
| Model Number | 6602125040 |
| Catalog Number | GB6602125040 |
| Lot Number | BYJ271 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | PERSTORP PHARMA PERSTORP 284 80 SW 284 80 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-16 |