MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-12-05 for ICEROSS SEAL-IN X I-SXT026 manufactured by Ossur Hf.
[129313621]
No indication of material or manufacturing failure could be identified based on information provided. This type of issue has not been recorded before as a result of this or predicate devices. No product was returned and analysis was performed based on information provided via medwatch. It is concluded that the subject is likely to have an underlying condition leading to the severity of ulceration. Diabetic patients and peripheral vascular disease patients are known to be ulcer prone which may also have contributed to said issue. As information is scarce in the claim and relation cannot be made to product malfunction, further action is not considered warranted.
Patient Sequence No: 1, Text Type: N, H10
[129313622]
Patient was fitted with a 1 1/2 in silicone band that felt like a "tourniquet", caused pain and developed a non-healing blood blister.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2018-00007 |
| MDR Report Key | 8132735 |
| Report Source | OTHER |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-05 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-12-05 |
| 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 | KATLA AXELSDOTTIR |
| Manufacturer Street | GRJOTHALS 1-5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal | 110 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICEROSS SEAL-IN X |
| Generic Name | LINER |
| Product Code | ISH |
| Date Received | 2018-12-05 |
| Model Number | I-SXT026 |
| Catalog Number | I-SXT026 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR HF |
| Manufacturer Address | GRJOTHALS 1-5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-05 |