MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-01-23 for ACTIVE ANKLE T2 277416 manufactured by Cramer Products, Inc..
[65504548]
The customer was given a new brace per customer's request. No other information given. All details of incident were not received until 12/24/16.
Patient Sequence No: 1, Text Type: N, H10
[65504549]
During an unrelated communication in (b)(6) of 2016, it was discovered that the user was wearing an ankle brace while playing volleyball and landed on another player's foot back in (b)(6) of 2015. The brace broke and the user rolled her ankle. She continued to play despite swelling and pain and was diagnosed the next day with a cracked growth plate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1910082-2017-00001 |
| MDR Report Key | 6269649 |
| Report Source | CONSUMER |
| Date Received | 2017-01-23 |
| Date of Report | 2017-01-20 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2016-12-01 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2017-01-23 |
| 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 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVE ANKLE |
| Generic Name | ANKLE BRACE |
| Product Code | ITW |
| Date Received | 2017-01-23 |
| Model Number | T2 |
| Catalog Number | 277416 |
| Lot Number | 022015 |
| 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. Required No Informationntervention | 2017-01-23 |