MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-07-29 for ICELOCK CLUTCH 211 L-211000 manufactured by Ossur H/f.
[904243]
"while patient was stepping down from a curb, the lock failed and the prostheses fell off. Patient broke his wrist as a result of bracing the fall. " the lock referred to above is used to attach a prosthetic limb to the hard socket which is fitted to the patient's residual limb.
Patient Sequence No: 1, Text Type: D, B5
[8103717]
Method: without possession of the involved device, it is impossible to conduct an evaluation of any value.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836248-2008-00001 |
| MDR Report Key | 1084682 |
| Report Source | 07 |
| Date Received | 2008-07-29 |
| Date of Report | 2008-04-09 |
| Date of Event | 2008-03-20 |
| Date Mfgr Received | 2008-04-09 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2008-08-05 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DICK SMITH |
| Manufacturer Street | 910 BURSTEIN DRIVE |
| 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 | REYKJVIK 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICELOCK CLUTCH 211 |
| Product Code | ISS |
| Date Received | 2008-07-29 |
| Model Number | L-211000 |
| Catalog Number | L-211000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1057517 |
| Manufacturer | OSSUR H/F |
| Manufacturer Address | REYKJAVIK IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-29 |