MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-03-18 for ACTIVE ANKLE T2 UNKNOWN manufactured by Cramer Products, Inc..
[40675086]
Historical review of cramer product complaints for retroactive mdr reporting identified complaint as mdr reportable. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[40675087]
Complainant states that on (b)(6) 2013 her daughter was injured practicing volleyball. She jumped and landed on top of someone else's foot then fell to the floor while wearing two t2 braces. The braces did not break, however, her daughter was diagnosed with grade 3 sprain, bone bruise, and a torn ligament.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1910082-2016-00003 |
| MDR Report Key | 5510503 |
| Report Source | CONSUMER |
| Date Received | 2016-03-18 |
| Date of Report | 2016-03-10 |
| Date of Event | 2013-09-04 |
| Date Mfgr Received | 2013-10-07 |
| Date Added to Maude | 2016-03-18 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA PIERO |
| Manufacturer Street | 153 WEST WARREN ST |
| Manufacturer City | GARDNER KS 66030 |
| Manufacturer Country | US |
| Manufacturer Postal | 66030 |
| Manufacturer Phone | 9138567511 |
| Manufacturer G1 | CRAMER PRODUCTS, INC. |
| Manufacturer Street | 153 WEST WARREN ST. |
| Manufacturer City | GARDNER KS 660301151 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 660301151 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVE ANKLE T2 |
| Generic Name | ANKLE BRACE |
| Product Code | ITW |
| Date Received | 2016-03-18 |
| Model Number | T2 |
| Catalog Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRAMER PRODUCTS, INC. |
| Manufacturer Address | 153 WEST WARREN ST GARDNER KS 660301151 US 660301151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-18 |