MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2016-01-25 for PERSTORP OINTMENT 40 GB6602125040 manufactured by Smith & Nephew Medical Ltd..
[36753750]
Patient Sequence No: 1, Text Type: N, H10
[36753751]
It was reported that the patient has receive local wound care with cadexomer iodine ointment. There was significant elevation in patients' serum and urine iodine level. Patient was started on methimazole and cardizem. He converted back to normal sinus rhythm.
Patient Sequence No: 1, Text Type: D, B5
[43857055]
Investigation result as no sample was returned we have been unable to perform an evaluation of the affected product. In addition, no batch information has been provided for this incident and we have been unable to perform a review of the associated batch manufacturing records. However it can be confirmed that each batch released to market undergoes full testing as outlined in the finished product specification, and must comply with all the requirements. It can also be confirmed that there have been no changes to the manufacturing process or raw materials used that may have caused or contributed to the incident highlighted in this complaint. The complaint files have been reviewed for the previous three years and incidents of a similar failure mode for the iodosorb product range are rare and this incident is not indicative of an adverse trend associated with this type of failure mode. Corrective action based upon the results of the investigation which has not been able to identify any known product quality defect, no further action will be taken at this time. However complaints of a similar nature will be closely monitored for any adverse trends and further action may be considered in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2016-00006 |
| MDR Report Key | 5387959 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2016-01-25 |
| Date of Report | 2015-12-28 |
| Date of Event | 2001-01-01 |
| Date Mfgr Received | 2015-12-28 |
| Date Added to Maude | 2016-01-25 |
| 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 | 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 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 | PERSTORP OINTMENT 40 |
| Generic Name | IODOSORB 40G |
| Product Code | KOZ |
| Date Received | 2016-01-25 |
| Model Number | GB6602125040 |
| Catalog Number | GB6602125040 |
| 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 HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-25 |