MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-08-14 for ICELOCK CLUTCH L-211000 manufactured by Ossur H/f.
[1096251]
"pt walked 8 blocks to gym. While entering the gym and going through the door, he came out of his leg and fell onto his prosthesis and dislocated his shoulder. He was in the hospital for 10 days"
Patient Sequence No: 1, Text Type: D, B5
[8295476]
Conclusions: the reported counter clockwise spin can occur if the clutch mechanism is not torqued to the force specified in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836248-2009-00002 |
| MDR Report Key | 1448855 |
| Report Source | 07 |
| Date Received | 2009-08-14 |
| Date of Report | 2009-07-10 |
| Date of Event | 2009-06-17 |
| Date Mfgr Received | 2009-07-10 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2011-03-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DICK SMITH |
| Manufacturer Street | 910 BURSTEIN DR. |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICELOCK CLUTCH |
| Product Code | ISS |
| Date Received | 2009-08-14 |
| Returned To Mfg | 2009-07-29 |
| Model Number | L-211000 |
| Catalog Number | L-211000 |
| Lot Number | HF081111 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR H/F |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-08-14 |