MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2016-10-17 for ICEROSS SEAL-IN V 34 I-471334 manufactured by Ossur Iceland.
[57619328]
Patient Sequence No: 1, Text Type: N, H10
[57619329]
A below knee amputee patient wearing the iceross seal in v 34 product spent several hours in a pub where he sat for about two hours. As he got up, the socket of the stump slipped. The liner remained at the stump. He and a glass both fell to the ground where he injured his hand on the broken glass and lost a part of his finger. The patient spent a week in the hospital and had his finger tip reattached. The patient lost his finger nail.
Patient Sequence No: 1, Text Type: D, B5
[59146565]
Patient Sequence No: 1, Text Type: N, H10
[59146566]
A below knee amputee patient wearing the iceross seal in v 34 product spent several hours in a pub where he sat for about two hours. As he got up, the socket of the stump slipped. The liner remained at the stump. He and a glass both fell to the ground where he injured his hand on the broken glass and lost a part of his finger. The patient spent a week in the hospital and had his finger tip reattached. The patient lost his finger nail.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2016-00007 |
| MDR Report Key | 6033583 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2016-10-17 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-09-15 |
| Date Mfgr Received | 2016-10-05 |
| Date Added to Maude | 2016-10-17 |
| 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 34 |
| Generic Name | SILICONE PROSTHETIC LINER |
| Product Code | ISH |
| Date Received | 2016-10-17 |
| Returned To Mfg | 2016-10-11 |
| Model Number | I-471334 |
| Catalog Number | I-471334 |
| Lot Number | HF160725 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-10-17 |