MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2004-01-14 for OSSUR ICEROSS LINER ICEROSS COMFORT LINER (LOCKING) I-010232 manufactured by Ossur Hf.
[329380]
The iceross comfort liner is usually the first component in a prosthetic leg. It is rolled on to the residual limb, and is made of a soft, stretchy material that acts as an interface between the hard, weight-bearing socket and the skin. The liner protects the limb and acts as an attachment to the prosthesis. Ossur iceross comfort liner is an ossur product and is produced at ossur hf. Co does not have any info about what types (ossur or someone else's products) of other components were used in the prosthetic leg. All following info was received from co's contact person, the prosthetist: description of event: the pt was walking at their house when the distal attachment tore out of the liner. The prosthetist thinks that the pt fell forward, since they put their hands out to catch themselves but they also said that there was no way to conclude how the pt fell. When they fell, they broke their wrist. Co does not have any info about why or how they fell, nor what broke in their wrist. The pt's wrist was put in a semi-rigid brace and then later in a cast. No further info is available regarding the treatment. The pt has other health problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2004-00001 |
| MDR Report Key | 547241 |
| Report Source | 04,06 |
| Date Received | 2004-01-14 |
| Date of Report | 2004-01-14 |
| Date of Event | 2003-11-30 |
| Date Facility Aware | 2003-11-30 |
| Report Date | 2004-01-14 |
| Date Reported to Mfgr | 2003-12-02 |
| Date Mfgr Received | 2003-12-02 |
| Device Manufacturer Date | 2001-09-01 |
| Date Added to Maude | 2004-10-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGRET ORMSLEV |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK 110 |
| Manufacturer Country | IC |
| Manufacturer Postal | 110 |
| Manufacturer Phone | 5151300 |
| Manufacturer G1 | ICELAND |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSSUR ICEROSS LINER |
| Generic Name | FORMFITTING SILICONE INTERFACE/COVER FOR LOWER LIMB AMPUTE |
| Product Code | ISH |
| Date Received | 2004-01-14 |
| Model Number | ICEROSS COMFORT LINER (LOCKING) |
| Catalog Number | I-010232 |
| Lot Number | 0137, 01=2001, 37=WEEK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 536648 |
| Manufacturer | OSSUR HF |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK IC 110 |
| Baseline Brand Name | OSSUR ICEROSS LINER |
| Baseline Generic Name | FORMFITTING SILICONE INTERFACE/COVER FOR LOWER LIMB AMPUTEE |
| Baseline Model No | ICEROSS COMFORT |
| Baseline Catalog No | I-010232 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-01-14 |