MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-16 for ICEROSS SEAL IN V 20 I-471320 manufactured by Ossur Iceland.
[40533283]
Amputee patient wearing iceross seal-in v 20 claims the seal tore and the patient lost the vacuum and came out of the socket causing a leg wound which required a wound vac for 3 months. The patient claims they developed patella tendonitis as a result.
Patient Sequence No: 1, Text Type: D, B5
[45874961]
Patient Sequence No: 1, Text Type: N, H10
[45874962]
Amputee patient wearing iceross seal-in v 20 claims the seal tor and the patient lost the vacuum and came out of the socket causing a leg wound which required a wound vac for 3 months. The patient claims they developed patella tendonitis as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2016-00003 |
| MDR Report Key | 5505710 |
| Date Received | 2016-03-16 |
| Date of Report | 2016-03-16 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2016-02-18 |
| Date Added to Maude | 2016-03-16 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Manufacturer G1 | OSSUR ICELAND |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICEROSS SEAL IN V 20 |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2016-03-16 |
| Model Number | I-471320 |
| Catalog Number | I-471320 |
| 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 | OSSUR ICELAND |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-16 |