MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-07-22 for RELIANCE 546 STOOL manufactured by Reliance Medical Products.
[2726494]
While user was positioning her foot on the footrest and shifting her weight, a ring clip broke resulting in the user falling. The fall resulted in a tearing of an acl in her knee. Surgery was required to repair the damaged knee area.
Patient Sequence No: 1, Text Type: D, B5
[10062013]
Device has not yet been returned to reliance med products. Only a visual review could be performed at user facility. Add'l eval will be performed upon receipt of device. Conclusion: results of the visual insp of suspect device were inconclusive. Attempts to recreate failure on like product in normal use settings did not result in clip breakage. Misuse of product can result in clip breakage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523545-2009-00001 |
| MDR Report Key | 2624087 |
| Report Source | 07 |
| Date Received | 2009-07-22 |
| Date of Report | 2009-07-21 |
| Date of Event | 2009-06-23 |
| Date Mfgr Received | 2009-06-23 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2012-06-25 |
| 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 | RUSSEL WOLFE |
| Manufacturer Street | 3535 KINGS MILLS RD. |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5133983937 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANCE 546 STOOL |
| Generic Name | STOOL, ANESTHESIA (BRX) |
| Product Code | BRX |
| Date Received | 2009-07-22 |
| Model Number | 546 |
| Catalog Number | 546 |
| Lot Number | 0109010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RELIANCE MEDICAL PRODUCTS |
| Manufacturer Address | MASON OH 45177 US 45177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-22 |