MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-03-15 for ICEROSS DERMO SEAL-IN LINER I-461323 I-4613_ manufactured by Ossur H/f.
[606723]
"walking with walker. Prosthesis fell off and she fell down and broke her hip. Patient is recovering from hip replacement surgery. "
Patient Sequence No: 1, Text Type: D, B5
[7924340]
Inspection of the liner shows nothing out of the ordinary. It seemed in good condition. There was most likely a user related loss of suction, ie patient did not step into the hard socket well enough to reach the required suction. There was no technical failure in the liner itself.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836248-2007-00002 |
| MDR Report Key | 831776 |
| Report Source | 07 |
| Date Received | 2007-03-15 |
| Date of Report | 2007-02-14 |
| Date of Event | 2007-01-15 |
| Date Mfgr Received | 2007-02-14 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2007-03-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DICK SMITH |
| Manufacturer Street | 910 BURSTEIN |
| Manufacturer City | ALBION MI 49224 |
| Manufacturer Country | US |
| Manufacturer Postal | 49224 |
| Manufacturer Phone | 5176298890 |
| Manufacturer G1 | OSSUR H/F |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICEROSS DERMO SEAL-IN LINER |
| Generic Name | ISS |
| Product Code | ISS |
| Date Received | 2007-03-15 |
| Returned To Mfg | 2007-02-26 |
| Model Number | I-461323 |
| Catalog Number | I-4613_ |
| Lot Number | 060721 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 819117 |
| Manufacturer | OSSUR H/F |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK IC 110 |
| Baseline Brand Name | ICEROSS DERMO SEAL-IN LINER |
| Baseline Generic Name | ISS |
| Baseline Model No | I-461323 |
| Baseline Catalog No | I-4613_ |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2007-03-15 |