MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-06-18 for OPTIFLEX 3 KNEE CONTINUOUS PASSIVE MOTION 2090 manufactured by Chattanooga Group.
[1608870]
Service of summons and complaint was mfr's first notice of this event. Plaintiff's counsel claims in the complaint that the pt had arthroscopic repair of her left knee. Post-op order by the surgeon was to place her on cpm for six hours on, six hours off. She alleges that following surgery, the pt was transferred to pacu and placed on the cpm on a gurney at approx 6:45pm. Treatment was discontinued at approx 4am. Plaintiff claims, she suffered a severe pressure injury on her right buttock. The gluteus muscle eventually began to necrose. The wound became inflamed and infected, and required multiple surgical drainage and debridement procedures, resulting in a significant loss of muscle, tissue and skin. Plastic surgery was done to attempt to reduce the cosmetic and functional deformities. Plaintiff claims, she has a decided limp and a gross deformation of her right buttock. The company has been unable to inspect the device. Because, the matter is in litigation, it has been turned over to outside counsel for further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-2010-00008 |
| MDR Report Key | 1730080 |
| Report Source | 00 |
| Date Received | 2010-06-18 |
| Date of Report | 2010-06-18 |
| Date of Event | 2007-03-05 |
| Date Mfgr Received | 2010-05-18 |
| Date Added to Maude | 2010-06-23 |
| 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 Street | 1430 DECISION ST |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | CHATTANOOGA GROUP |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLEX 3 KNEE CONTINUOUS PASSIVE MOTION |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2010-06-18 |
| Model Number | 2090 |
| Catalog Number | 2090 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN 37343 US 37343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-06-18 |