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..
[40675765]
Historical review of cramer product complaints for retroactive mdr reporting idenified complaint as mdr reportable. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[40675766]
Subject was playing volleyball and landed off a block and the ankle brace snapped, causing complaintant to roll right ankle, resulting in tearing two ligaments and bruises.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1910082-2016-00002 |
| MDR Report Key | 5510472 |
| Report Source | CONSUMER |
| Date Received | 2016-03-18 |
| Date of Report | 2016-03-10 |
| Date of Event | 2014-01-09 |
| Date Mfgr Received | 2014-01-11 |
| 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 |
| 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 660301151 |
| Manufacturer Country | US |
| Manufacturer Postal | 660301151 |
| 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 |